clinical development Archives - NonClinical Physicians

Land a Pharma Clinical Development Job: A PNC Classic from 2021

John Jurica — Tue, 25 Jun 2024 11:02:17 +0000

Interview with Dr. Laura McKain – 358

In this week's show, an interview from the archives with Dr.Laura McKain explains how to land a pharma clinical development job.

Our guest, Dr. Laura McKain, is a board-certified physician with more than 10 years of pharmaceutical industry experience. She has managed clinical-regulatory strategy, study design, protocol writing, Phase 2, 3, and 4 clinical trials, medical monitoring, safety surveillance, data analysis, and report writing.

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From Clinical Medicine to Clinical Development

Laura received her medical degree from Georgetown University in Washington, DC, and completed her training in obstetrics and gynecology at Virginia Commonwealth University in Richmond, Virginia. She was in private practice for twelve years where her clinical interests included well-women care, contraception, HPV, menopause management, as well as general and high-risk obstetrics.

Anybody that feels miserable and trapped… You may feel like you have no options but, I promise you, you have a thousand different options. – Dr. Laura McKain

Subsequently, Laura transitioned her career to the pharmaceutical industry. There she was involved in clinical development projects encompassing various therapeutic areas. During her tenure, she brought two new therapeutics to market.

Land a Pharma Clinical Development Job

She recently retired from full-time work. That allowed her to focus on helping other physicians find new nonclinical careers. She does that in several ways. And she is very confident that almost any physician in practice can make a move to a pharmaceutical job.

She is a career coach and resumé expert at mckainconsulting.com. And, she founded the Physician Nonclinical Career Hunters Facebook Group. Opened 8 years ago, it now serves 30,000+ members. It is the premier group to connect with other physicians, find job openings, and obtain valuable advice and mentorship about nonclinical careers.

During our interview, she described the tactics she recommends to find a clinical development job. She also defines job descriptions used in the pharma industry, and which jobs are the easiest to secure.

Summary

Dr. McKain provides lots of actionable advice in today's interview. She is a great resource for information and coaching about nonclinical careers. And she continues to grow her popular Facebook Group where you can learn more about how to land a pharma clinical development job.

NOTE: Look below for a transcript of today's episode.

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Today's PNC Podcast Transcript

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Transcription PNC Podcast Episode 214

How Does a Physician Land a Pharma Clinical Development Job?

John: Today on the podcast I really hope to bring more clarity to the issue of jobs and pharma, particularly those in clinical development. My guest today is definitely an expert in this topic. She's a physician coach. She's a resume consultant or expert, whatever you want to call it. And she's also the founder of The Physician Nonclinical Career Hunters Facebook group, which I think most of you know about. Dr. Laura McKain, hello, and welcome to the podcast.

Dr. Laura McKain: Hi John. What a great pleasure to finally be here with you today.

John: I know. We've known each other for quite a while and it's like, why have we not been able to get together on this thing? But it just happens that way sometimes. Yeah, I've been really looking forward to talking to you, and my listeners probably know this, but you have so many areas of expertise and you've been doing this for so long. It's not just the pharma part, but the helping physician's part that I'm already going to put a bug in your ear about coming back on the podcast to cover another topic sometime in the future.

But we're going to really pick your brain today. First thing we need to do is just learn a little bit more about you. I have a separate intro that I did, but give us high points of your background and your career and what you're doing now.

Dr. Laura McKain: Absolutely. I'm a board-certified obstetrician gynecologist. I practiced in private practice for 12 years before transitioning over to pharma more than 13 years ago actually. I worked first in a couple of contract research organizations. And then I took a big leap and moved over to a startup biotech company on the west coast. Actually, I just recently retired from that company, after my drug got approved. I'm just tremendously passionate about my own career. Actually, I think I've had two careers, as well as my career transition from clinical medicine. And I am just incredibly passionate about assisting other physicians to make sure that they're really satisfied in their professional life.

John: That's fantastic. There has been such a demand over the last few years. And I don't know about you, I assume you've seen the same thing, but it was sort of something that people didn't ever talk about or didn't know about until now there are just physicians all over the place, including in the Facebook group looking for help and making the transition. That maybe doesn't bode well for the practice of medicine and all the hardships that are driving that, but it's definitely something that's growing.

Dr. Laura McKain: I absolutely agree. And I'm hoping that physicians can find perhaps other ways to find work-life balance without necessarily completely leaving clinical medicine.

John: Yeah. I think we talked a lot about making a transition, but always building it on that background in medicine, the knowledge of healthcare. Pharma is an awesome place to do that in my opinion. I've never worked in pharma, but we've interviewed MSLs and medical monitors and others, but really have had minimal exposure to the topic I hope to talk to you about today, which is clinical development or drug development. Tell me a little bit about what is that? I think we have our own understanding about it. It has to do with bringing drugs to market, but tell us what clinical development is as a division in pharma and what it does.

Dr. Laura McKain: Absolutely. Clinical development truly it's a blanket term that is used to define the entire process of bringing a new drug or a device to the market. It includes everything from the folks in the lab that are doing drug discovery, actually looking for molecules that might work, to the folks that are in product development, including the preclinical research, that may be done in microorganisms or in animals to early-stage clinical development where people are doing first in human studies to the later phases of clinical development, which involved the large clinical trials on humans that lead more directly to approval of a new drug. It's a broad range and there are actually a lot of different roles for physicians across clinical development.

John: Now, when I think about physicians in clinical development, I think about those maybe who went directly into academics, or they were doing research as part of their training. But what I think you and I tend to run into are physicians who have already been in practice for a while, they're thinking of leaving and now they want to transition back into some aspects. Maybe give us a little bit more of an idea of what jobs are in there that would be the most appropriate for physicians looking to go from clinical into that division of work.

Dr. Laura McKain: I think there are a lot of options and some of them may actually be things that physicians haven't even really thought about, particularly ones that still actually rely upon a lot of physician's clinical skills. One of them to start out with, and I'm going to start before a physician actually becomes employed by either a contract research organization or actual pharma company is to be a principal investigator in clinical trials. While you're still interacting with patients, it's very different than having a sick patient come to you for an answer.

When you're a clinical investigator, you're actually conducting industry sponsored clinical trials that are aimed toward getting a drug approved. And it is a fabulous role for somebody who feels like they have no experience in pharma or they feel like they don't have anything that they could put on a resume to get them their foot in the door with pharma. It's a great way for physicians to work on building that book of experience to make that transition.

And there are a lot of different settings for principal investigators that they can use their skills and to build this experience. For instance, they could work for actually large phase one units, which there are many across the country, where you're actually a full-time employee and you are enrolling patients, oftentimes, folks who are participating first in man trials, or they are doing studies like pharmacokinetic studies, to understand how new drugs are metabolized. Many of these types of facilities are actually inpatient facilities because they sometimes need to keep the patients for days in order to do the needed studies on them. They love employing emergency medicine physicians in this role, because again, it's a first demand drug. So, it's a great use of skills.

But there are also a lot of freestanding dedicated research sites that are either privately held or that a lot of physicians develop on their own to do later phase clinical trials. Think about like "Where did all of our trials that got us COVID 19 vaccines come from?" They were not done at academic institutions. Some of them definitely were done at academic institutions, but a lot of them were done in freestanding clinical research sites with principal investigators that were family practice docs or internists or from other specialties.

John: Okay. I'm going to dig into this a little bit, just to clarify for me and the listeners. Let me just give an example. I'm at a hospital where I was a CMO and we had an IRB and I sat on the IRB and we had these protocols come through. Most of those were external. And then we had people that were on staff at the hospital as part of that study, but would they be called a principal investigator or they would be an actual site from a study that was being produced either by the company directly or a CRO? How does that work?

Dr. Laura McKain: It really kind of depends upon how things are contracted, but you're right. Some physicians who are acting as a principal investigator, they may use their local institutional review board, the IRB, the committee that's required to review protocols to ensure that they are appropriate for patients. They may use a local IRB to conduct this research, but something that you may not know is that there are a lot of what we call central institutional review boards. IRB is that free standing units, not associated in any way with a hospital or an academic institution will use as their approval body for conducting this research.

Again, it really varies. There are some physicians that even act as a principal investigator within their own practice. They use a central IRB to get that approved. And they do it just part time. I've conducted many studies with lots of investigators who have that sort of setup. And then some of them love it so much they transitioned more and more away from actually seeing regular care patients and move toward doing clinical research on a full-time basis.

So, there are a lot of different settings where clinical research gets done. Academic institutions, hospitals, privately held investigational sites and then mom and pop organizations that physicians have started on their own.

John: All right. I hope I wasn't confusing anyone that's listening about the IRB. I think our IRB when we were involved with, let's say a national study and we happened to be at site, we were more just monitoring it. And there was a central IRB that approved the overall protocol, but we might have an oncologist on staff who was just enrolling patients into a study or urologist. I think he was more involved with procedures or in ortho doing certain implants. So, that did give them an exposure. And I didn't personally know anyone that used that and went into more of a full-time, but you're saying that's definitely a segue where you can say, "Look, I've been doing these studies, I've been monitoring patients. And so, why not do that full-time or something like that?"

Dr. Laura McKain: Absolutely. I've worked with lots of folks that have been principal investigators for industry sponsored research, and have used that as leverage to get a job with a pharma company. Absolutely. It's a great way because you already know how protocols work. You know so much that you would need to be able to know from the other side to be a medical monitor or what have you.

John: Would those people look at the firms, the companies that they were helping with their own study, or they look somewhere else? They say, "Look, I've got this experience in oncology" as the easiest way to use the company that they're already affiliated with, or could they just go to a CRO or some other company?

Dr. Laura McKain: Oncology is kind of a separate beast in terms of clinical development. Let's kind of just set that aside because a lot of oncologists, as part of their regular practice, do offer their patients the opportunity oftentimes last-ditch effort to enroll in study. So that's a little bit different. Let's talk about developing a new diabetes drug, or as I said, a vaccine. I did women's health studies. Those spokes are how they get their studies, how they find them really varies. Generally, some of them begin because they have relationships with contract research organizations, or they may work through what's called an SMO - Site Management Organization who helps them to find studies. And then there are some people who have just been doing it for so long that the companies come to them when they have a potential study. So, there are a variety of different ways here.

John: Okay. I guess that brings me to the question then, how would a physician other than being involved in something like that position themselves to move into pharma more directly? Are there things they can do beyond that that would help bolster their resume? What kind of suggestions would you have for that?

Dr. Laura McKain: You mean beyond being a principal investigator?

John: Yes. Or instead of if they haven't happened to be a principal investigator.

Dr. Laura McKain: I think there are a number of things that physicians can do to demonstrate that they have an understanding of how clinical trials work and what the work that they may be doing at a contract research organization or a pharma company. It definitely helps if you've got some clinical research experience but it could be something just as simple as being a real supporter of clinical research and being somebody who refers your patients to potential clinical trials. Getting great familiarity with clinical trials through that sort of pathway. So, physicians, let's say gastroenterologist. They have patients who have Crohn's disease which is very difficult to treat and they haven't found the right drug. They may help their patients find clinical trials to enroll in to offer them other potential options for successful treatment. That's definitely one way.

Other ways if you're a physician and you have absolutely no experience, would be to do a lot of reading, quite frankly. Really pay attention when new drugs are getting approved. Really look at sort of what the end product of new drug approvals are. And specifically, that's the prescribing information. Those long little leaflets that come that come with the drug. They're like 27 pages long. That's the end result of a clinical development project and really understanding what's in those documents and studying those sorts of documents and understanding the lingo and how they get to it. Looking at the published trials that come from new drug development, the pivotal phase three trials that are submitted as part of the new drug application.

Just getting that education and being well versed in it, being able to speak about it is great. If you're involved with drug reps at all, getting the word out that you're potentially an early adopter of a particular product and asking to speak with your regional medical science liaison to develop relationships with an MSL, to maybe get on a speaker's bureau for a drug. Actually, that was one of the ways that I got into the industry. I had been part of a number of speakers' bureaus for products that I really, really, really believed in. And that counted for me as being industry experienced, believe it or not.

I think another important thing is to potentially become a key opinion leader in your area. Choose some niche in your practice, something that's really of interest. Particularly, it's kind of nice if it's something where they're doing ongoing research. And become an expert. You should be the person that people refer patients to, have passion for it, really specialize in it.

And then last, but certainly not least what I always say is you should be networking. You should be networking. You should find people in the industry, find out what they do, do informational interviews with them, et cetera, et cetera. And those sorts of experiences can help you get your foot in the door with either a contract research organization or with a pharma company.

John: Does it seem like one works better than the other in terms of a CRO versus directly with a pharma company or does it just depend?

Dr. Laura McKain: I think there are certain specialties that can leap over to pharma much more easily. We already mentioned it, oncologists. If you're an oncologist out there listening, getting a job in pharma, it's as easy as falling off a log. I'm exaggerating, I know I'm exaggerating, but there are some specialties that are in tremendous domains. There are other specialties that I think have a much more difficult time. I've worked with a couple of folks like radiologists. I have really had a hard time trying to find an avenue for radiologists to get in. I'm not saying it's impossible because I know radiologists who've worked in clinical development, but it's probably a little bit more tough. Although even with that, there are angles for their careers.

We're kind of getting off on a tangent here, but there are companies that provide services to clinical trials, where they do very standardized assessments of certain diagnostic studies. A radiologist could go to work for one of these companies that does what we call "centralized readings" to make sure everyone's x-rays or what have you gets read in exactly the same way using exactly the same criteria. And I've worked with many radiologists who've gotten into that business. So, there are a lot of different avenues. There are lots of possibilities depending upon your specialty. Nothing's really off the table.

John: Very interesting. It can be overwhelming in a way. But you mentioned the KOL or key opinion leader and influencers and so forth. I mean, that's kind of the jargon they've heard from MSLs for example, and I'm sure there's a lot of other jargon. So, what about the titles themselves? What would be the jobs that a physician is looking at getting? Is it a medical director position? Is it a clinical scientist? If they're just trying to look around now, maybe look on Indeed or LinkedIn or somewhere just to look at a job description, what should they look up if they're looking for that kind of a job at a CRO or a pharma company?

Dr. Laura McKain: Sure. It does depend upon how much experience you have and where you might need to aim if you're looking to work for a contract research organization or for a pharma company.

I would say that generally speaking, a board-certified licensed physician who's looking to make this transition but maybe you don't have a lot of experience. I think a safe job title to pull up is an associate medical director position. And if you're entering it into LinkedIn, I put "Associate medical director clinical development", very specifically to look for those sorts of jobs. At a contract research organization, you're that type of role. You're really going to be serving as what we call a medical monitor.

It's actually not very common to find jobs titled as medical monitors. You can find them, but they're less common. Typically, the overarching term is an associate medical director or a medical director. But you would be performing that sort of role. You would be monitoring clinical trials, providing medical oversight to clinical trials in an associate medical director role in clinical development.

Going up the food chain from their medical director, senior medical director, executive medical director, some companies do or do not have this would lead them into a VP role. And then ultimately to a chief medical officer role. Obviously, those are all demanding experiences, but associate medical director is a good place to start.

For some people, even that may be kind of too high to aim. And another role that you can look for is a role as what's called a clinical scientist. And you can find those at pharma companies and also some contract research organizations. A clinical scientist is kind of the right hand to the medical monitor on a clinical trial. They still need to have a lot of clinical experience. They need to be very familiar and know a lot clinically to be able to review data.

They will play supportive roles to medical monitors, particularly on really high-volume studies. Again, I keep going back to our recent example of, "How did we get these COVID vaccines?" I guarantee there was like an army of clinical scientists out there that were helping to monitor the data, and to summarize it for the applications which got us emergency use authorization.

But clinical scientist is a great entry role. You'll find some physicians in that role, you'll find potentially foreign ex-US trained physicians in that role, but you'll also find PharmDs and even PhDs in that role. But it can be a potential place to get your foot in the door.

And then let's talk about the person who perhaps graduated medical school, but didn't do a residency or somebody who didn't complete a residency, or again, I'll even go back to somebody who graduated or trained outside of the US who's never been licensed here.

You talk enough about this, or we don't talk enough about that group of people, but there are roles in clinical development for those folks also. And I have worked with many people with the background that I've just described who serve as a role as a clinical research associate. And they often work for contract research organizations and they are fully trained on clinical trial protocols. And they actually go to the sites that are conducting the research. I'm really simplifying this, but they ensure that the data has integrity, that it's not fraudulent data, that it's been entered into the database correctly, that the site has conducted the study according to the protocol, with like I said, great integrity and they reported everything that they need to report.

Those clinical research associate roles are extraordinarily important. They definitely require a great medical background. I often see nurses in that role, other paramedical people in that role, but I've also, like I said, I've seen foreign trained MDs in that role. And it can be a foot in the door for pharma.

I built a drug safety team at one of the companies that I worked at. And I actually promoted a couple of people who had served as CRA's clinical research associates to drug safety physicians because they had all the medical know-how and they knew about clinical trials and they were great people to promote up to a more traditional physician role. So, there are lots of opportunities out there.

John: Oh, that's very helpful. I don't want to digress too much, but you mentioned this person, just this last bit here, that they were promoted into a safety role. This is just because in my mind, I'm trying to keep the parts of a pharma in my head and I tend to break them down into sections. So, I kind of think of the safety as standing by itself. It's not really part of clinical development. I don't think it's part of medical affairs. It doesn't kind of straddle all those things because it's maintaining safety.

Dr. Laura McKain: It does. Think about the role that safety plays in clinical development. When a company is developing a drug, there are two things that they are trying to establish. They're trying to establish the efficacy of the drug and also the safety of the drug. If the drug isn't safe, it doesn't matter if it's effective or not. You can't approve it. The pharmacovigilance department, the drug safety folks played an enormous role in clinical development.

And in fact, the clinical development people work very closely with the safety folks. And there is a ton of communication that goes on between the two groups. They review and analyze data together. Although the clinical development people are responsible for collecting the data, the pharmacovigilance people are really important in terms of meeting the regulatory requirements during development, but also, they play a huge role in the development of the actual applications when they go in. There is a ton of overlap.

And I'll tell you, John, that folks who work at contract research organizations, their positions that they get as a medical director are oftentimes really hybrid positions where they are responsible for medical monitoring, but they also can play a huge role in safety and they get very well versed in the regulatory requirements about both of those.

Of course, it's my experience, but I think contract research organizations are an amazing learning field for physicians who want to get into industry because you really get a broad view of things and you get to work with a bunch of different pharma companies to see how things are done differently at different companies. And it makes it much easier I believe to go onto pharma from there.

John: That is very helpful because we need to know how to get our first job. That's the hardest part I think from what I understand. Once you're in, then you can look around, you can continue to grow and learn and maybe shift. I just want to summarize things here though. I want to go back to the beginning. I'm in a position where

I'm thinking about doing something like this, but at the beginning, as you said, do your research, learn as much as you can, network. And I would assume also in some cases like physicians you've helped, get a coach, maybe that can help navigate this with you, if necessary, because it can get very confusing. Are you still doing coaching for physicians at this time?

Dr. Laura McKain: Absolutely, I do. I do work with individual physicians. And I'll be honest, I've really sort of narrowed my focus. I was kind of taking all commerce for a while, but I really have honed in on folks that are more interested in moving into pharma. I work with them to help them really mine their own background, their own experience to find those transferable skills that make them qualified for pharma. But I also can coach them on finding opportunities to build that runway to make the leap over.

John: All right. I do have to put the plug in now. It's at www.mckainconsulting.com.

Dr. Laura McKain: Yes. And check the show notes to make sure you get my last name spelled because it's a tricky one.

John: Right, right. So, that's one way you're helping people. Now, you're also helping them through the Facebook group so we have to spend a few minutes talking about that. Give us the entire history of the Facebook group in two seconds. No, I'm kidding. Just give us an overview of what's going on there.

Dr. Laura McKain: I established it five years ago, really just because of my own passion around this amazing second career that I've had. I really love my clinical career but I just feel like I've had this amazing second career I've gotten to. I've had two drugs that have gotten approved. I've literally traveled the world. I've gone to see how medicine is practiced all over the world. It's really been phenomenal. I just feel really privileged to have been able to do this. And after I got out of clinical medicine, I had lots of physicians, friends, and whatnot coming to me, "How would you do? How would you do it? How would you do it?" And I started the group to try to answer that question. And it has grown extraordinarily organically.

John, you've been an absolutely important administrator for the group for many years that have really helped us to truly grow organically. I mean, the group has sort of grown on its own. I will say. There has not been a lot of effort that's gone towards building it. We're up to almost 17,000 members at this point. We're fortunate that we've got a number of different experts in a variety of nonclinical settings that are really offering expertise to the group.

And then most recently, I made some changes in the group. And now because it's becoming more work to administer the group, we have a number of awesome sponsors for the group. John, you're one of our platinum sponsors for the group because of all of the contributions that you've made. But there have been a couple of individuals and one company that have stepped up to provide a little bit of financial support to kind of keep the thing moving and rolling.

But it's a great place for physicians to come to get exposed to people that are doing a variety of different things, non-clinically, as well as getting advice about navigating a transition. I think more and more our group is also helping to assist physicians who are just really feeling burnt out and maybe transitioning out of medicine isn't the right thing. But I think some of them are all saying they are finding appropriate connections within the group. "Maybe I just need to change my clinical practice and stay". So, I think we're beginning to kind of service that group also.

John: Well, that's good. That's awesome. And you're right. A lot of it is basically just people that are unhappy and they'd need support and they're getting encouragement with all physicians, 100% physicians, obviously. Yeah, I like all the new changes that you've made in the last several months and I think there are more coming. But it's a great place to go if you just don't know where to go, who to ask for advice on how to move into a nonclinical career or something like direct patient primary care or concierge med. All these things that are alternatives to the traditional practice that may be causing your brain to fry physically.

Dr. Laura McKain: A lot of the stressors seem to come from some sort of corporate medicine right now. People really do need to know that there are alternatives there and for anybody out there who's listening that feels miserable and trapped, you have to know that you may feel like you have no options, but I promise you, you have a thousand different options. It just takes some courage to find the thing that'll work for you. It may be something nonclinical, but you know what? I think there is also a great chance that there are answers if you want to stay in clinical medicine. Probably not what you expected me to say today, John.

John: No, no. I have guests on frequently that it's like if you can figure out a way to practice that isn't corporate medicine, because it's just killing you then by all means, do it. I certainly want to have a doctor for myself.

Dr. Laura McKain: Oh, yeah. And there are maybe people that can do things part time. Like I said there are a lot of people who have a clinical practice, but they also act as a principal investigator and that variety in their life makes things more doable for them. There's a lot of different ways to find happiness professionally. And I encourage everyone to do it. Don't wait. This is not a dress rehearsal.

John: Absolutely. I'll put a link to the Facebook group, but if you look up "Physician Nonclinical Careers" or "Nonclinical Careers", you'll find the Facebook group. I would encourage if you're not already a member to join there. There is a little vetting. You have to answer some questions, but if you're a physician, you can join. Is there anything else I'm missing in terms of places we should look for you? I think you're on LinkedIn, for sure.

Dr. Laura McKain: I think that's plenty. I'm in the Facebook group every day, now that I'm retired. Of course, once I've retired, I've got little quotation marks. I'm still doing pharma consulting and some other things, but I'm really doing it on my terms now. But the Facebook group definitely is a place to find me and mckainconsulting.com is another place.

John: All right. Well, it looks like we're about at the end here. Any last bits of advice for the listeners today?

Dr. Laura McKain: The last piece I would say is that if you're really seriously considering transition, I accomplished my transition solo and I don't recommend that. I think that now there are so many more resources and places to go for help. Rather than groping your way in the dark, reach out for help. It's worth it. I swear to you, I'm not trying to sell coaching services. I just hate to see people struggle. There are opportunities for people to get real professional help that can make the process much more efficient.

John: Very good words of wisdom there, reach out for help. And it goes all the way back at the beginning, when you were talking about networking and talking to others and learning. So, that's great. All right, Laura, thank you very much for joining us today. I'm definitely going to hold you to come back again and talk about some other things. So, with that, I'll say goodbye.

Dr. Laura McKain: Bye John. Thank you.

John: You're welcome. Bye-bye.

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The post Land a Pharma Clinical Development Job: A PNC Classic from 2021 appeared first on NonClinical Physicians.

Making Your Way to a Rewarding Career in Clinical Development – 308

John Jurica — Tue, 11 Jul 2023 12:40:41 +0000

Interview with Dr. Linda Ho

In today's episode, Dr. Linda Ho returns to the podcast to discuss working in pharma in clinical development. And she explains how she moved into this role after starting as a medical science liaison.

During our interview in September 2018, Dr. Ho described her shift from clinical medicine to work as a Medical Science Liaison. In today's interview, she stands out as the first physician on the podcast to describe her transition from Medical Affairs to Research and Development.

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Exploring Clinical Development

Dr. Ho describes her professional journey, transitioning from MSL to a position in clinical development (CD). With enthusiasm, she explains these two areas within the pharmaceutical industry.

Drawing from her own experiences, Dr. Ho highlights transitioning to CD:

She began learning about clinical trials at her company, even as she worked as an MSL.
Networking is crucial, including making connections with local MSLs and sales representatives to find out about opportunities and express interest in transitioning.
Joining a contract research organization (CRO) as a starting point to enter the pharmaceutical industry can be an option, but it may not guarantee a direct path into clinical development.
Physician Development Programs offered by big pharmaceutical companies are an excellent way for young physicians to enter the industry. These programs provide rotational experiences in various departments, allowing physicians to explore different functions and decide on their preferred career paths. These programs are also known as Physician Fellowships, Physician Leadership Development Programs, or Pharmaceutical Leadership Development Programs.

Transitioning in the Pharmaceutical Industry

For an MD, it's a natural transition to do something that is more MD related. I use my medical background every day, assisting physicians with managing adverse events and providing insight into patient cases. While the ultimate management is up to the Principal Investigator, I can advise them on available resources and discuss the case given my knowledge about the drug and the program.

She also highlights the importance of networking and showcasing experience in team management during job interviews. Having experience in managing timelines and resolving conflicts within a team, even if it's not an official managerial position, can be highly valuable.

Summary

Dr. Linda Ho's remarkable career journey exemplifies the possibilities and opportunities that exist within the medical field. Her successful transition from Medical Affairs to Research and Development serves as an inspiration to aspiring professionals seeking growth and fulfillment.

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Transcription PNC Podcast Episode 308

Making Your Way to a Rewarding Career in Clinical Development

- Interview with Dr. Linda Ho.

John: Today's guest, in my opinion, has gone through at least two major career transitions. The first was when she went from clinical work to being an MSL in pharma. But I saw recently that she is now working in clinical development, which is to me a big switch from the MSL work. So, with that, I want to welcome Dr. Linda Ho back to the show. Hi, Linda.

Dr. Linda Ho: Hello. Hi.

John: It's good to have you back. I can't believe it. I was looking at the dates and it's been really like five years since we spoke. I always refer to your episode quite a bit because it's really a good one for people getting an introduction and thinking about moving into an MSL role because you had a lot of great advice back then.

Dr. Linda Ho: Thanks. Yeah, that was super fun. I think that was sort of at the end of my MSL gig, moving on to clinical development.

John: All right. Yeah, I think it was. And so I really am interested in hearing about what's been going on since then, but maybe you want to give us a short thumbnail, kind of explanation of why you switched from clinical to nonclinical. Just briefly, because I can refer people back to the old podcast. And then what attracted you to move from the MSL role to the clinical development role?

Dr. Linda Ho: Geez. I was working at a vein clinic for a while. I'm a pathologist by trade, but I never loved pathology. And I worked at a vein clinic for a while, and then one of my patients while I was at the clinic said that, "Oh, you would make a great MSL." And I was like, "Why? I don't, I don't know what that is." And she explained that she was a sales rep for a pharma company and explained to me what an MSL was. And I was already at that time thinking of a career transition. So, it seemed like a perfect fit.

It did take me a while to find an opening that would take a chance on someone who wasn't already an MSL. I think that a lot of people probably find that challenge when they're looking to transition. But eventually I did, and I was an MSL I think for five, six years maybe, at a few different companies. And then in the fall or late summer of 2018, I moved into clinical development.

I developed an interest in clinical trials, while I was an MSL. And also the travel of an MSL really started to wear me down. At first it was super fun. I loved racking up the miles. I loved flying here and there, but the amount of time spent in an airport was really starting to wear on me. So, that was one of the main reasons for looking for a new role.

John: That makes a lot of sense. And we talked about that last time, and that is one of the things that comes up quite a bit. And depending on the size of your territory, and I remember you had maybe at least at one point a pretty large territory.

Dr. Linda Ho: Yeah.

John: Now that was pre pandemic.

Dr. Linda Ho: Yes.

John: I'm kind of hearing now that post pandemic with everyone trying to be as remote as possible, that some of the MSLs are actually doing more of their work remotely than they were before. But that wasn't going to help you out.

Dr. Linda Ho: Yes, correct. That was a few years too late for me.

John: Yeah. Yeah. Now, what was interesting about clinical development and what does clinical development mean? I hear terms like clinical research, I hear primary investigators. I hear different things thrown out. And so, would it be right to say just clinical development means working on new drugs or new medical devices if it happens to be in the medical device company? What does that mean exactly?

Dr. Linda Ho: Clinical development falls under the research and development umbrella, the R&D umbrella. And it's really the department that generates trial data. Whether it's phase 1, 2, 3, or preclinical data, that generally falls under the clinical development umbrella.

Now, we work very, very closely with our colleagues in clinical operations, which is different. And the subtlety of that is clinical operations, they work on trials as well. However, they're generally not as involved in the data generation or clinical trial design or strategy behind it. They execute the clinical trial strategy that development creates. They have not just in-house staff, but also field staff that go to the sites where we're conducting the trials. And they go through the data and make connections with people at the site level, make sure that the data is looking good on that end.

So, it's a distinction. It's a fine distinction, but it is there nonetheless. And it can be very confusing like what's the difference between development and operations? What are these two different terms? So, hopefully that clears that up.

John: Yeah, that helps. The other thing that I think not all companies necessarily use all the same terms too, that we see from company to company, it seems like they have sometimes slightly different terminology.

Dr. Linda Ho: Yes.

John: And I spoke to someone recently who is working as a principal investigator, but she's working as I guess I could say a PI. But I think from talking to her, she's actually working for a CRO or a third party, and she's responsible for one site where the research is done. But I'm assuming in a pharmaceutical company in the R&D area, where they have a study, it could involve dozens if not hundreds of locations. And that's kind of a different level.

Dr. Linda Ho: A principal investigator to my understanding are generally the investigators at specific sites. So, for example, if we have a site, I don't know, I was just going to make up one, say University of Illinois. The physician who is at that site is the primary investigator. And you have different sites with different primary investigators, PIs, we call them. And they are responsible for ensuring the safety of the patient, appropriate management of the patient, appropriate reporting of that patient's data, managing any adverse events, that kind of thing.

John: All right. And so, in that situation, would that be considered the part of clinical operations in most companies or part of research and development?

Dr. Linda Ho: They are not hired by the company. They are a physician at that particular hospital or institution. So, doctor so-and-so who is going to be named in the study as an author, that is our principal investigator at that particular site.

John: Got it. Okay. Yeah. So you can understand why someone who's never been involved working around pharma can get super confused. So tell me a little bit more about what interested you instead of maybe going into something that was in clinical operations or medical affairs, which like I said, I kind of get the idea that most MSLs are in the medical affairs division. What was it about the clinical development that really appealed the most to you?

Dr. Linda Ho: I think you're right that most MSLs move up into either an MSL manager role where they're in the field and they're managing other MSLs in the field, or they move into a medical affairs role. Now, medical affairs is responsible for the strategy and the management of the asset or drug as a whole, as opposed to clinical development, which manages the data and the trial subjects.

Now, I did not have a lot of exposure to clinical development as an MSL. I sort of had to seek that out on my own. But I became interested when I was in my last MSL role because I took it upon myself basically to provide a tool for the MSL team to use in the field collating all of the studies that were being conducted with the asset that we had at the time.

The team was new, the department was new, so that kind of tool did not exist. But it was super helpful to have, because investigators will ask you, or KOLs will ask you, "Well, what trials do you have going on in this area? Well, what studies do you have that are looking for subjects?" These are very basic questions that an MSL gets. And it's hard to be like, "Well, I don't know." Or to be like, "I'll get back to you on that." You kind of want to have something right then and there that you can pull out and reference.

And so, I created quite a large spreadsheet to help with that. And I became interested like, "What does CTM mean? What is CPM? What is the difference? Oh, look, they're conducting this with this, they're conducting this combination in this population." And that's sort of how I became interested in development.

John: All right. So now you've been doing the clinical development for how long?

Dr. Linda Ho: Five years now.

John: Five years. Okay. Now looking back, and if you were to give advice, let's say to others who either are MSLs or maybe they're doing something else in medical affairs and they wanted to switch into what you're doing, what kind of advice do you have for them to try and get more experience or exposure to something that might help them actually make that transition?

Dr. Linda Ho: For an MD it's a natural sort of transition to do something that is more MD related. I use my medical background every day. Whether it's managing adverse events, assisting physicians, they'll send me an email like, "Oh, such and such patient had febrile neutropenia or had a grade three rash. What should I do? How should I manage that?" And so, I can give them some insight into that.

Now, ultimately, the management is up to the PI. It's not up to me. I'm not putting in orders or seeing the patient, but I can advise them on what kind of resources exist and basically talk through the case with them, given my knowledge about the drug and the program.

John: Yeah. If I think back to when we spoke and with others I've spoken in, of course, there are positions for PAs and NPs and PharmDs and PhDs in the MSL role. But like you said, for those that are MDs, DOs, that have the actual patient care background, there are certain advantages I could see based on what you just said.

Dr. Linda Ho: Definitely. There are a few PharmDs. I have known a few PharmDs. It is rare though. It is relatively rare. You have to have a very strong clinical background. I do know a few PharmDs, but yes, mostly it is MDs and a few MD PhDs that do this kind of work. Because it is very clinical.

Now as far as your previous question, your original question about the transition, it was pretty challenging for me. My prior company, they tried to get, because med affairs and clinical development are like two different departments technically. Yes, they're over the overarching umbrella of R&D but especially in a large pharma, there's definitely a separation. You kind of have to make your own opportunities. And my last company, they tried, they did try to get me there, but at the same time, they want you to do your regular MSL job, which is 40 plus hour week job.

For me, going back to the original job hunting tips that I gave before, it's really about networking and finding another person who's in development who's willing to take a chance on you. Showing your interest in development, showing what kind of experience you have with managing a team. It doesn't have to be a study team, any kind of small team, to get to achieve your goal is helpful.

And they will ask you about that during an interview. "When have you managed a team? What was your role? How did you resolve conflicts in that team? How did you make sure that everything stayed on time with the timelines?" That's very important, timelines. To have that as much experience, managing, it doesn't have to be an official managing. You don't have to have the title of manager, but to show that you've worked on a study team in some capacity before is really helpful.

John: Okay. Now you talk about networking. Would one focus, depending on the size of the company, on internal networking, in other words, working with or networking with those in the company, maybe in other divisions, in other locations, let's say, or try to network more with those outside of your current company? Does LinkedIn help with that? How do you do that networking?

Dr. Linda Ho: You want to start with internal. You have a good reputation within the company. People can speak for you within the company. So, it's always easier to start internally. Now, there may or may not be positions available depending on the company and where the assets are at. They may not have the ability to take you on. And in that case, that's when you really turn to LinkedIn as well as networking at conferences. That is really key, I found more so than LinkedIn.

Yeah. You can reach out to them on LinkedIn, make a connection, but then say, do you have time to meet up at ASCO, meet up at ASH, meet up at whatever college of whatever? That's really where a lot of networking occurs in person networking.

John: And these would be conferences that you would normally be going to anyway as part of your role at the time. And they're more general though, because they involve different members of the overall team.

Dr. Linda Ho: Correct. Assuming that you want to go into development in the area that you are currently in. Gynecology or whatever. Gastroenterology. And most likely the company that you're looking at, the development leads will also be attending, I don't know, gastroenterology meeting. And so, you can say, "Do you have time to meet up at DDW? Do you have time to meet up?" And everyone's got a little bit of time. There's downtime in between sessions, and also at lunch, where you can meet someone really quick for coffee or to grab a sandwich, find a corner and talk.

John: Yeah. No, that makes perfect sense. And particularly if you can piggyback on something that already is on the schedule, just have to make sure to verify that both of you are going to be there. That could be quite useful. Yeah, it really does build on what you said in our previous interview about not relying on some kind of electronic format of communication, which can go nowhere.

Dr. Linda Ho: Correct. Most likely go nowhere.

John: Yeah.

Dr. Linda Ho: That frustrate you and make you very depressed.

John: Any other just off the top of your head or on your list there of anything in particular that one might want to do to help facilitate that transition?

Dr. Linda Ho: Do you mean as an MSL or as a physician looking to get into industry?

John: Either one. I was thinking more as if you're already the MSL, but if there's something different from what we had discussed before, because things have changed. It's been five years.

Dr. Linda Ho: Yeah. There's just been minor things like global pandemics and things like that.

John: Yeah.

Dr. Linda Ho: If you're a physician looking to get into industry, I think the best way to move into clinical development is to A) have experience in clinical trials and B) the lead in clinical trials. The more papers and trials you have under your belt, the better candidate you are. And then again, networking. So, making connections with your local MSL, with your local sales rep, and through them finding out who the people are in the company to talk to and meeting them at conferences to express your interest in the transition.

I personally have known and helped multiple physicians get into industry through this method alone. Meeting them at meetings, talking with them, making that connection. And then when someone says, "Hey, we have an opening for a medical monitor for this particular trial", then I can say, "Oh yeah, I talked to person X, Y, and Z and they have expertise in that and I think they'd be a good fit." And that, to be honest, is more valuable if you're a hiring manager than anything else. To have someone that you know vouch for their work is far more valuable than anything else.

John: Okay. One of the things that's come up, we are kind of shifting gears a little bit, and some of the people that are trying to break into pharma are contract research organizations. I think maybe they're CROs because they seem to have a lower barrier to hiring certain types of positions, although they're not as secure because they fill in gaps like an MSL.

Dr. Linda Ho: Yes.

John: Someone I think that got in that way. They were hired by a CRO as a writer, a medical writer, and then ended up getting into pharma. So, any thoughts on that whole approach to if you've struggled to get in in other ways, whether that would be useful or not?

Dr. Linda Ho: To get into development, you mean?

John: Well, to get your foot in the door in pharma through a CRO to begin with. And then maybe from there, try and use the steps that you're talking about to move into directly working for the pharmaceutical company. Maybe as an MSL and the CRO, and then move into the MSL position in the company. And then next step is to then network and build, get into clinical development that way.

Dr. Linda Ho: That's a long road. That's a long road and not necessarily a guaranteed road.

John: Yeah.

Dr. Linda Ho: For young physicians, if you are fresh out of residency or fellowship, or maybe just been an attending for a few years, and you're like, "No, this is for the birds, this isn't for me." The best way, the very best way to get into pharma in any capacity is to do a physician's development program. The very, very best way.

The PDP program is available at many different big pharmas. I don't think any biotechs or small pharmas have these programs, but I could be wrong. I could be wrong. But the PDP is tailored and developed for physicians to kind of get their feet wet in many different functions in a pharmaceutical company. I think it's a two-year program, and basically you rotate through different departments. You'll rotate through affairs, clinical development, safety, manufacturing I think. All sorts of different capacities where a physician might belong in a pharmaceutical company. It's like residency all over again. You'll have three months here, six months there, and you'll have projects to work on and different things to work on.

And then when you finish, when you graduate at the end of your two years, you have had your toes in multiple different capacities and can say, "Oh yeah, I really loved safety. I really hated medical affairs." And you can decide where you want to go into. And the company will help you. They'll either hire you outright after you finish the program or help you get jobs at other companies. It is the very, very best program.

I honestly wish that I had known about this program when I was looking. I would've applied in a heartbeat. They are fairly competitive. When I was an MSL and trying to get into development, I learned that my company had this program and a lot of the development physicians had come from this program and I wanted to apply and they told me I was too old.

John: Yeah. I don't know that much about these, but I've heard some people have talked about so-called residency or a fellowship with a pharma company. I think it's the same thing. The terminology might be different, but they're kind of competitive, like you said. And I'm assuming because it's a full-time thing, correct?

Dr. Linda Ho: Correct. It's a full-time thing.

John: So they pay you, but it's again, not going to be like you get paid if you were actually working for the company. Is that true?

Dr. Linda Ho: This, I don't know. I'd have to look more into it. I think it is fairly competitive. Maybe not if you were in full-time in that capacity. But I don't know. Certainly they pay you enough to live and to relocate to wherever the home office is and that kind of thing.

John: Okay. All right. Before we go, I wanted to get back to the lifestyle and the other things you like about what you're doing now. I'm trying to get a sense. I usually like to ask about whether people can work remotely in the job that they're doing. Is it everything face to face? Is it 09:00 to 05:00? There is the traveling, obviously, of an MSL. So why don't you just tell me what your experience has been in terms of the lifestyle and quality of life and working in this position?

Dr. Linda Ho: Prior to the pandemic, we were in the office four days a week. You could take one day to work remote. And so, I think I chose Wednesdays or something to work remotely, and that was great. But for the most part, you were in the office. And it was pretty much 09:00 to 05:00.

Sometimes there were early days if you're talking to the EU, and sometimes there were late nights if you were getting ready for a publication or for a data cutoff or something. And those happened fairly regularly. Data cutoffs were every quarter. So at least for a week or two, every quarter it was 12 hour days.

And like you said, there was not the traveling commitment that there was as an MSL. I very much enjoyed the more regular schedule. I think in my younger days maybe I liked being out there and traveling so much. But I think as I got older that started to get more and more difficult.

John: Did that change at all after the pandemic in terms of the amount of time that you could be working remotely?

Dr. Linda Ho: I think it took them a while to figure things out. My particular company, currently, if you decided during the pandemic that you're going to be remote, you could maintain your remote status. However, they are not hiring any more remote people.

John: I don't know. I've heard things, it could be a double-edged sword too, in terms of you can kind of go crazy sometimes if you're just home all the time and not interacting with people.

Dr. Linda Ho: That's true. But you can also get a lot of work done.

John: Yeah. And not be on the road and driving back and forth or whatever it is. That's just a waste of time to some extent, plus the expense.

Dr. Linda Ho: Yes, I knew someone who was working at a pharmaceutical company in San Francisco, but during the pandemic moved back home with his parents in LA. And given the housing prices in San Francisco, it actually made more sense for him to fly back and forth weekly. It's a short trip. It's an hour and a half flight maybe. And to go fly back and forth, and pay for a hotel then to try to buy something in San Francisco.

John: Yeah, that makes sense. Heck, I was doing a 90 minute one way round trip to a job I had in the Chicago area for a while there when I was a medical director. So, that's an hour and a half on a plane and you're not even driving. You can get other work done.

Dr. Linda Ho: Yeah.

John: All right. Well, I've taken up enough of your time today, Linda. This has been very interesting. It's been really good. You give us a little more insight into clinical development and the interaction and the ways to move between these jobs. I still have a lot of people that listen to this podcast that are just burned out and frustrated. And now you've been out of clinical for quite a while, but any last bits of advice for someone who's looking at "Why do I have to go into this clinic every day?" before we let you go?

Dr. Linda Ho: I think more and more people are feeling similarly. People reach out to me on LinkedIn or wherever, and actually there's quite an active group on Reddit I found.

John: Oh, really?

Dr. Linda Ho: Yes, yes.

John: Oh, I'll have to look for that.

Dr. Linda Ho: Yeah. Reddit is pretty much totally anonymous. So, people feel safer asking questions and trying to get advice. They burn you out in residency, and you think it's going to get better after that, but it doesn't really. And yeah, you get paid a lot more money than you do when you're a resident, but the money isn't everything. It isn't everything.

I think that a lot of people are feeling more and more similarly in that the way that the hospitals are going these days, where they're run by administrators and MBAs, where they're really pushing for productivity, it's just counterproductive as far as physicians are concerned. I personally think that the PDP is a great way to go if you are trying to find out where you fit, if you fit in a pharmaceutical company sort of environment. There's a lot of other options out there.

I found out that a lot of people, they work in the legal system as an expert witness. They can make quite a bit of money doing that. And that is also a good route to go. I know that there's a conference, I spoke at it once. What's it called?

John: The annual conference for SEEK.

Dr. Linda Ho: For SEEK, yes. SEEK. Yes. And there are a lot of speakers there who have different experiences in different areas outside of regular old medicine that are also good options.

John: Yeah, absolutely. I guess a question I would have, it seems to me that the positions that are available for physicians in pharma and other industries, there's still plenty of positions out there. There's lots of job posting. So, there are options that you can do that are much more easy to do in terms of your lifestyle and not putting in 80 hour weeks and being on call every third day, all night and that sort of thing.

Dr. Linda Ho: Yeah, I agree. Hiring has slowed down though a little bit. I've heard a lot of people sort of complaining about that the hiring has slowed down as the economy slows down.

John: Right.

Dr. Linda Ho: Hopefully, that will turn around soon.

John: All right. Well, again, thank you for being with me today, Linda. This has been a good update and maybe we'll swing back around about five years from now but we'll talk before then. But I really appreciate it, this has been fun. And so, with that, I'll just say goodbye.

Dr. Linda Ho: Sounds good. Thanks for having me.

John: You're welcome.

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How to Navigate the Challenging Pivot from Family Medicine to Clinical Research – 306

John Jurica — Tue, 27 Jun 2023 19:30:00 +0000

Interview with Dr. Melissa Choi

In today's episode, Dr. Melissa Choi takes us through her career journey to a position in clinical research. She shares the motivations behind her career pivot. And she offers valuable insights into how she navigated the transition to her first nonclinical position.

Dr. Choi is a family physician who successfully transitioned to a career in the Pharma Industry. With a background in clinical research, she now serves as a Principal Investigator (PI), leveraging her expertise and passion for medical advancements.

Our Sponsor

We're proud to have the University of Tennessee Physician Executive MBA Program, offered by the Haslam College of Business, as the sponsor of this podcast.

The UT PEMBA is the longest-running, and most highly respected physician-only MBA in the country. It has over 700 graduates. And, the program only takes one year to complete.

Her Journey to Clinical Research

Dr. Choi embarked on a journey that led her from internships and bench research to the field of obesity medicine. As a family physician, she initially aimed to practice part-time but soon realized the challenges of solo practice and the lack of collaboration. However, her growing interest in obesity medicine sparked a change.

Driven by her desire for control and independence, Dr. Choi embarked on an entrepreneurial path. With the guidance of a business coach, she learned essential skills. These included creating a professional online presence, optimizing her LinkedIn profile, and understanding marketing strategies. These efforts eventually paid off. A recruiter noticed her updated LinkedIn profile and reached out to her about applying for her current role.

Dr. Melissa Choi's Advice

If physicians are interested in a role like this or even another nonclinical role, I would suggest doing a reflection of what you enjoy and what you're an expert in. Learn to market the skills and expertise you have, even if you may be frustrated with the job search. Figure out what you want to go toward, not just what you're running away from. And ask for help.

Summary

Dr. Choi's journey demonstrates the importance of patience, adapting to challenging circumstances, and seeking opportunities for personal growth. And she benefitted from applying entrepreneurial and marketing principles to shape her career path.

She highlights the role of LinkedIn. It served her as a:

platform for recruiter outreach,
place to build connections, and
resource for conducting research.

She also noted the value of showcasing transferable skills and problem-solving abilities during interviews.

Dr. Choi provides an overview of her role as a PI in a research site. And she described her job duties:

overseeing clinical trials,
ensuring participant safety,
collecting accurate data, and
managing various tasks related to the trials.

Her proactive and enthusiastic approach contributed to her successful transition to a nonclinical pharma role.

NOTE: Look below for a transcript of today's episode.

EXCLUSIVE: Get a daily dose of inspiration, information, news, training opportunities, and amusing stories by CLICKING HERE.

Links for Today's Episode:

Download This Episode:

Right Click Here and “Save As” to download this podcast episode to your computer.

If you enjoyed today’s episode, share it on Twitter and Facebook, and leave a review on iTunes.

Podcast Editing & Production Services are provided by Oscar Hamilton

Today's PNC Podcast Transcript

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Transcription PNC Podcast Episode 306

How to Navigate the Challenging Pivot from Family Medicine to Clinical Research

- Interview with Dr. Melissa Choi

John: Today's guest transitioned from primary care medicine to clinical research. Something that can be difficult to pull off, at least from what I know. So, today I want to find out why she made that shift and how she did it. Dr. Melissa Choi, welcome to the podcast.

Dr. Melissa Choi: Thank you so much for having me here, John. I'm a big fan of your podcast. So, I'm looking forward to this discussion today.

John: Well, I'm happy to hear that. I like having people that have heard the podcast before, sometimes our guests never have, but that's cool. This is really interesting. We connected on LinkedIn and I saw what you were doing. I said, "Wow, how did she go from family medicine into clinical research now working as a PI", which you'll explain what that is. But we'll get started by you. Just tell us a little bit about your medical education, clinical background, and I know you did different things there, and then we'll get into the nonclinical part after that.

Dr. Melissa Choi: Absolutely. I sort of have a non-traditional medical background. I was admitted to Brown University's eight year combined Bachelor's MD program, which if folks aren't familiar with, you get admitted basically to medical school when you're 18 years old, a senior in high school. And the thing that I liked about Brown's program is there were fewer sort of prerequisite courses we had to take. I didn't have to take my MCATs, which was fantastic. I had all these great opportunities where I could study abroad and as an undergrad, take classes like architecture history. And I really loved that experience and I wouldn't trade it in. But I would say maybe one of the downsides of my medical experience was that I never really had to stop to think about if medicine was really what I wanted to do.

And I don't doubt that I wouldn't have chosen this path, but it was sort of like I just kept going through, which I think maybe many of us do. But I really didn't have to think about what I wanted to do from undergraduates through medical school. And so, I got to medical school, got onto my clinical rotations and I loved everything I did. I loved pediatrics. And then when I moved on to neurology, I loved that. When I did psychiatry, I loved that.

I think that's really what brought me to family medicine because I enjoyed everything. And when I was on rotation I was like, "This is great for four weeks, but I'm not sure if I want to do this every day of my life forever." And so, that's sort of how I ended up in family medicine.

John: Nice. Let me comment on a couple things there. First of all, making this lifetime decision when you're 17 or 18 years old, it sounds great. "Wow, it's locked in. I don't have to compete with anybody now that I already got this." But it reminds us that our child brain isn't even mature yet till we're like 23 years old. So, we're making these big decisions. They can go wrong sometimes when we do that.

Dr. Melissa Choi: Absolutely.

John: It sounds like you really enjoyed it. It doesn't sound like, this is a prequel to what we're going to talk about later, that you did a lot of, let's say, clinical research in there. Or did you? I didn't see any special master's degree or anything in that. Is that correct? You kind of did traditional and plugged right through.

Dr. Melissa Choi: During the summer times in college and right before medical school I did some internships. I did one opportunity doing a lot of bench research where working with pipettes, things like that, just to have that experience. But I knew that's not what I really wanted to do. But I got some experience understanding what an IRB was and what a protocol was. But compared to what I currently do, it really is not very similar at all.

John: No. Well, knowing what an IRB does, that's a good bit of knowledge. Some physicians have exposure to that as they go through their careers and some never do. But that I know could be a little bit helpful. Well, then tell us what happened. You went through and after medical school, you did the family medicine residency. Let's take it from there and what happened in the next few years after that.

Dr. Melissa Choi: Yeah. I will say I'm kind of one of those rare braids that loved residency. I had a great time. I loved working on teams and was excited to go into practice once I was done and I said, "Hey I'm just going to go into outpatient medicine. I'm going to practice part-time." And I thought it was going to be this great setup.

And I think early on I realized the challenge of sort of practicing on your own. Number one, I really missed working with the team. When you're in practice, it's sort of myself and the patient and there's not a lot of collaboration. So I realized I missed that early on. And then number two, while I enjoy studying all parts of the body, doing different systems, when you're in practice, when you have 20 or 30 minutes to solve everything, it's really challenging.

And so, early on I had a difficult time but I sort of wanted to think independently and say, "Okay, well, this is challenging." But I quickly realized that for family medicine, at least, a lot of these problems that I'm trying to manage like diabetes, hypertension, even osteoarthritis, a lot of these are caused by the same thing. People who are overweight or obese.

And so, I started getting really interested in obesity medicine maybe about three or four years into practice and sort of looked into what it entailed to become an obesity medicine physician and took it upon myself to become board certified in obesity medicine.

And then I basically started to set up my own clinic within my clinic to be a weight management physician in a primary care setting. I allowed my partners to even refer patients to me. And it really gave me an opportunity to do something that I was interested in and it helped sort of that burnout feeling I was starting to get.

John: Yeah, I think when one of the things as family physicians, because we're not specialists, we get to see everything and most of it is chronic, then the really acute sort of things we can't do much for anyway, like a cold or something in between. It gets overwhelming because it just never stops. And when you can do something like obesity medicine, weight management or whatever, you can focus and you can spend more time usually it seems like, you can educate people more. That's the thing I thought about when I was in practice is those kind of things were more interesting than just grinding through the office every day.

Dr. Melissa Choi: 100%. And what I liked about obesity medicine is sort of what drew me to family medicine in the first place. I wasn't just looking at one problem. Obesity medicine is multifactorial. There's behavioral, there's psychological, and I got to have the time and spend the time with my patients to discuss those things. And so, I was able to sort of feel like I had control of my clinic even though I was in an employed setting.

John: Did you feel like you were having some success with the patients too? If they came in and they were really motivated and interested, they would actually learn something and change their approach?

Dr. Melissa Choi: Absolutely. Many of my patients, you sort of look for at least a 10% to 15% weight loss and to be able to maintain it a year or more. And so, to be able to have those sort of metrics to see the progress that they've made and their gratitude toward you definitely helped my practice. And I think if it weren't for COVID, I may still actually be doing that right now.

John: Okay. It sounded like things are going pretty well. Everything sounds like they're going in the right direction. And for my audience you'll hear my voice is cracking because I've had COVID recently, so I'm just recovering from that. But anyway, tell us though, that was not the end point. You all of a sudden or at some point got interested in something else. So, tell me more about that.

Dr. Melissa Choi: I mentioned COVID kind of changed the trajectory for myself and I think for many of us. So when COVID hit in March, 2020, I'm working in an employed setting, they said, "Hey, we're trying to decrease the number of resources that we need. And since not that many people are even working in person, let's sort of hibernate your clinic and move you to another clinic." And I said, "Sure, no problem." Thinking this would be a couple months and I'd get back to with my partners, things like that. And the challenge came when a couple months became a couple more months and then they finally said, "You know what? We're shutting down your clinic." And like most people, you like the team that you're with, you like the MAs you have, you like the partners you have.

And even though I eventually settled at a good clinic, COVID changed so many things for our practice. And because I wasn't in an employed setting at the time, there were just a lot of things I didn't have control over. I didn't have control over my schedule. I was told that I needed to start early or work late until 6:00 PM. And it became really challenging for me. And so, what I actually did was, I told myself I needed to find an opportunity to do something where I felt like I had control and it was something within my own interest.

And so, I actually started doing some health coaching, but prior to that I actually found a business coach to work with. And I thought that that was really important because I'd never started my own business or even knew what that entailed. And having somebody that had done something prior to me stepping into this role was really important because they basically showed me the ropes. And along with creating a more professional looking website with professional photos, they told me I needed to spruce up other social media avenues, including my LinkedIn profile.

And so, I spent the money to get professional photos, spent a couple hundred dollars, spoofed up my LinkedIn profile and I actually was not doing too bad. And I think for myself at least having an outlet where I could pursue my interests, have control actually made the day-to-day clinic easier for me to get through, knowing that I had something that I could do on my own terms. And interestingly I think partially because of the way that I had updated my LinkedIn profile with a photo, sort of a brief blurb of what I did, I had a recruiter just reach out to me about my current role as a PI.

John: Okay. Now, I just want to clarify because that's pretty awesome. You were focusing, you had the business coach and you were focusing on being like a coach yourself. Was that the business model at the beginning?

Dr. Melissa Choi: Yes. That was the model. And this business coach wasn't necessarily for coaches, she was just a coach for physicians that were interested in starting their own businesses.

John: Right, right. The business side of it, finances, accounting and LLCs and all those kinds of things like how to actually set up your own business.

Dr. Melissa Choi: Yes. And in addition to that, I think a big thing that I learned was how to market either yourself as a brand or your business as a brand and how to really tap into what people are looking for. And I can talk about this later, but I think that actually helped in terms of me landing my current role.

John: Applying those marketing principles, was that basically on the website in the LinkedIn profile, other places?

Dr. Melissa Choi: I think it's the interactions that I had with people. From a business standpoint it was the way that I presented myself on Instagram at the time that was my avenue that I did. But like I said when this recruiter reached out to me, and I started interviewing, I really used a lot of those marketing strategies that I had learned to really market myself for this role.

John: Okay. Well yeah, take it from there in terms of the recruiter. Tell me more about that. What was it that appealed to them? And when you talked to the recruiter, what did the recruiter say that appealed to you and made you pursue this at that point based on what you could determine they were looking for?

Dr. Melissa Choi: Yeah, I just one day randomly got a DM in my LinkedIn inbox saying, "Hey, we have this nonclinical full-time role in the Twin Cities", which is where I'm based. "And we're looking for somebody that is motivated, looks to have some leadership skills. Are you interested in discussing?" And all those things piqued my interest. And so, I responded and got on a phone call with them.

And one thing that I learned early on too when I'm preparing for these interviews is to really research the person that I'm going to speak with, sort of their background. Even if it's something simple like, "Hey, they're from Arizona." In this situation, when I got on the phone call with them, we were talking about the weather because it was July and it was very hot there. So, we chatted about that and just being able to make a connection with that recruiter.

And at the time he told me this was a nonclinical position, but I wasn't even really sure what it was. And once he got on the phone with me, told me I would be a principal investigator and explain the role to me. Even though I wasn't quite sure what it was, I quickly tried to figure out what are the skills that I have, the leadership skills that I've gained in my clinical experience that I could sort of share with them. And I think he appreciated the enthusiasm, those skills that are transferable into this role. And he was then able to move me on and say that I could meet with the hiring manager.

John: Okay. And I'm going to ask you questions about that for sure. But before we do that, getting back to LinkedIn. LinkedIn has different ways of connecting people to you and you to them. So you didn't actually use the job board, you weren't looking in LinkedIn for reaching out to the recruiter. The recruiter found you. Now there's a setting in LinkedIn that says you're open to employment or open to jobs. I'm assuming that was on. Are those basically the parameters that you set up with your LinkedIn?

Dr. Melissa Choi: Yes, that is correct. And I had certain job titles. I think sometimes people talk about the medical director role, things like that. But to be honest, at this point in my career, there's medical directors for insurance companies, there's medical directors for pharma companies. I wasn't even quite sure what I was looking for, but I had those options on at the time and there must have been something that piqued his interest.

John: Yeah. At a high level, the fact that you're looking to do nonclinical, that was one thing that probably some of the recruiters key off of. And once they looked at your profile, there were probably examples of things you had done that, like you said, demonstrated transferable skills and into other settings. And like you said, you didn't even know this was in the pharma industry initially, right?

Dr. Melissa Choi: Correct.

John: Okay. So then the next person you talked to there, what was their role?

Dr. Melissa Choi: Yeah. He was basically the executive director overseeing multiple PIs within the company.

John: Okay. Now, were you able to do any research on that person? Or were they like a black box when they linked up with you?

Dr. Melissa Choi: Yeah, I did my homework before this interview. And that's one thing I would tell other physicians if they're looking to transition to a nonclinical role or a role that they didn't do. One of the first things I did was research all the people I would be interviewing with, including this hiring manager. And again even though he was in pharma, I also found out that he had a family medicine background.

And so, when I jumped on the call with him or the interview with him, I talked about bonding over this family medicine background. And interestingly the site that I work at, they really are like a general medicine research site. They oversee trials in all sorts of therapeutic areas. And so, they were really looking for somebody with my general background. Not somebody that was a specialist.

And some of the other things that I did to prepare for interviews was I listened actually to podcasts that talked about preparing for interviews and was prepared to answer common questions. And I would say one of the most common questions is "Tell me about yourself." And one thing that I learned from podcasts, from my coaching background is they want you to tell them about yourself, but not really tell them about yourself. They want to know what I can do to help solve their problem.

John: Yes.

Dr. Melissa Choi: When you're answering that question, you don't need to talk about how you were a chess champion when you were 12 years old. You need to talk about your experience that's relevant to what their problem is. And so, I made sure that I prepped those sorts of common questions, made sure I had a good answer for that.

And then I think the other thing that my background as a coach in business and also learning about marketing is being able to answer questions with stories. Because when somebody says "Tell me some things that you're good at." If you say I'm good at organization, that doesn't really say anything. But if you can tell a story about "this is what I did, this was the problem, and I was able to solve it in this particular way", that'll really give them an image of what you can complete. And so, I made sure I had some of those experiences that I was able to share with them.

John: Yeah. Perfect. You mentioned other podcasts where this has been discussed. I think I have discussed it, but Marjorie Stiegler comes to mind and Heather Fork and there's probably others who have really had guests on. Those are the kind of things you were listening to and preparing with?

Dr. Melissa Choi: Yes. I actually listened to both of their podcasts and I even just googled general interview podcasts because they don't necessarily have to be physician specialized, which is helpful. But I think just having the knowledge of common questions including behavioral questions, strengths and weaknesses, making sure you know how to answer those questions are important.

John: Yeah. It's interesting to talk to someone whose interview goes absolutely bad and then in retrospect they go, "Now I know what I did wrong but I didn't know it at the time." Now let's turn it around to you. So, what was it about this position that intrigued you enough or interested you enough to say, "Yeah, this sounds great, I'm going to take this after jumping through all the hoops?"

Dr. Melissa Choi: Yeah. Maybe to talk a little bit about the role as well too. Like I said, when I first heard about this job, I wasn't even sure what a principal investigator did. I sort of knew what a PI was because of some of the academic research I had done. And in those sort of academic settings, PI often will have a question or curiosity and they'll sort of create their own trial.

But in this instant, a principal investigator like myself working at a research site, basically, I'm working as the physician that takes responsibility of a trial that a sponsor which is like a pharma company asks us to do. So, let's say Pfizer has a new drug that they would like to run a trial on. They need to find somebody to manage that. My current role at my research site is that I'm the physician that will take on the responsibility of a trial and I will have multiple different trials that I'm responsible for currently. And what that means is I need to carry out that trial based on what the protocol has written. I oversee safety and make sure that safety is protected and also oversee all the data that's collected, making sure that it is clean and accurate. So, that's sort of the high overview of what I do.

And day-to-day, it is an onsite job. I don't work from home, but there are different tasks. I have to review charts that my coordinators have worked on. I do need to evaluate participants to make sure they're safe. And if an adverse event does occur, I need to report it based on the timelines of the protocol that they're asking for and make a determination whether I feel like this is associated with the drug or the IP that they're currently looking at or not.

And then there's lots of meetings, with either monitors, medical monitors, sometimes the protocol changes. So, I need to be up to date on that. And so, kind of going back to what I had mentioned earlier in terms of my personality. I really enjoy working as a team. And so, the role that I have, I need to work with a lot of different people. And that was one of the best things about taking this role.

The other thing is it's kind of the best of both worlds because I get to be in pharma and get to be part of potentially bringing a new drug to the market. But I still get to see participants, we don't necessarily call them patients, but I still get the interaction with participants during this time.

And then the other thing is I do need to use my medical background to sort of determine things such as eligibility criteria, if they're able to participate in a study. And again, being aware of adverse events, I need to be reviewing labs and EKGs. However, I'm not managing all of those things. I think one of the hard things for at least a family physician when we're in practice, we're often managing 10, 20 problems per patient.

And here even though I may see them and interact with them, if they is something going on, say their creatinine starts going up while they're in this trial, I need to make sure, "Oh, this is something that's concerning, but you need to go follow up with your PCP." And so, it takes off some of that pressure of managing every single problem.

John: Okay. I have questions. I have a lot of questions. I maybe won't hit you with all of them today, but as you were talking earlier about what a PI is and what a PI does, in my mind over the years, even way back before I went to med school I think of clinical researcher and a PI, it's like they're an academic person, they're creating this multi-site study, we're going to try this drug and on all these patients and they're the PI for that.

But you're talking about PI as it's a role. It's a position in this organization that has certain duties and it's basically to exceed at this particular study at this site, it's done properly and safely and all those things. Is that pretty much what I'm hearing?

Dr. Melissa Choi: Yes, that's correct. I think the biggest difference between my role and an academic's role is pharma companies or what we call sponsors are looking for people to sort of run their trial, but they need physicians to oversee it. And that's where my role as a PI comes in and they said, "Hey, we have this trial, can you help us oversee it at your site and help recruit patients to participate in this trial?"

John: Now would there be similar studies being done at other locations that are parallel that either someone else would be running or you would in your role, maybe if not now in the future, where you would run at other sites? How does that play out? Do you know?

Dr. Melissa Choi: Yeah, absolutely. I think it depends on what phase of the trial it's in. A lot of the studies that I'm currently participating in are in phase two or three. And when they're in a phase three trial, for example, they're looking for 18,000 plus subjects. And there's no way that one site can manage that. They're looking for a diverse patient population. So, a lot of these times, the sponsor or the pharmaceutical company will have the same trial running in all different countries around the world. So, it's really fun to see how this comes together. And so, in that instance, I'm just a small portion, but my data is still contributing to moving a potential drug forward to market.

John: And would there be occasions where you would be interacting with the other PIs kind of doing the same thing that you're doing at other sites and you're part of this massive team?

Dr. Melissa Choi: Absolutely. Before COVID, I didn't have this job until after COVID. I heard that before COVID, there were a lot of in-person investigator meetings. And those can be located anywhere. And they would be flying PIs like myself to these meetings.

It doesn't happen as often now because they've discovered they can do these meetings online via Zoom, but I have also gone to investigator meetings in person where you meet together and I actually really like the interactions. It's a great way to meet other investigators. You get to meet the sponsors who are the staff that I often interact with via email. Seeing them face to face is very helpful. And it's just easier to ask questions about the protocol, say, "Hey you wrote this, did you mean this?" when I have questions about the protocol.

John: Now, as I was trying to understand the pharma industry, which was really foreign to me, and I probably still don't understand it fully. In my mind, pharma companies have different divisions and the activities are separated from each other, but it's probably not really true because there's probably a ton of overlap. And what I mean by that is that in my mind, safety and pharmacovigilance, I think those terms are used interchangeably and separate from the clinical research or the clinical development division, which is separate from the medical affairs division. And so, are those sort of arbitrary distinctions? It sounds like you're doing a lot of safety, but is there another safety professional that you interact with as well that's part of the team?

Dr. Melissa Choi: Yeah. And I wouldn't even necessarily categorize the role of a PI in sort of the safety pharmacovigilance role because at least from my understanding, those folks are looking at data and signaling things like that. I feel like I'm actually independent of those three categories that you've mentioned and I am the physician that's basically running the trial that clinical development has developed, for example. But I do interact with the safety folks such as medical monitors. Say I have a question in terms of I'm not sure how to interpret this eligibility criteria. Is it okay to enroll this patient in this trial? And they would say, "Yes, based on what you've told us, go ahead and enroll this subject in the trial." And so, those are the times when I interact with the medical monitor.

John: Okay. Yeah, to me it always seemed too, as I got into it that all these people were interfacing with one another. Even in the hospital setting, you have departments, you have divisions, but everybody has what we call a matrix reporting in the sense that you just interact with whoever you need to interact with. You don't have to go through your boss to do something if there's an issue that you need to deal with at the hospital. Well, it sounds very similar in this kind of organization.

Dr. Melissa Choi: It really is. Because I would say I interact with the medical monitors, but then there are times that I have to interact with the trial managers. And so, they're all sort of separate but together. So yes, there's a lot of matrix leadership that's going on.

John: All right. Well, I've probably gone over my time here with you, but let me just put it out this way, a question. Is there anything that we've skipped over in terms of the process that you followed and the way that you've found this job, your feeling about the job, pros and cons, anything we've missed that you want to mention before I let you go?

Dr. Melissa Choi: Yeah, I think if physicians are interested in a role like this, or even another nonclinical role. Obviously, people say network and apply, but I think some of the other things that I would suggest is, first of all, really do a reflection of what it is you enjoy and what are you an expert in.

In my case, I sort of took this twisty, windy, unexpected role. I was doing health coaching and that was something that I was really interested in and I was really interested in obesity medicine. And I think when you learn to market the skills that you have and the expertise you have, and even though you may be frustrated that you're applying to lots of jobs, but not getting interviews or not getting offered a role, you get to do something that you can be the expert in.

And those believe it or not, will help sharpen the skills to lead you to where you may eventually want to go. And I always tell folks to figure out what you want to go toward, not what you're running away from. I know there are a lot of physicians that are burned out based on what we've gone through the last few years. But it's really important to kind of understand why you're burned out and figure out what it is you really do enjoy because that will make even the time that you're still practicing more enjoyable.

And I would say the last thing is ask for help. Look for physician coaches or people that have done something that you're interested in and speak with them. I think a lot of times as physicians, we are thinking that we're smart folks, which we are, but we think that we can figure it out on our own, which you may, but again, it may take you much longer if you do it on your own than if you speak to someone that's already done it.

And I always tell myself professional athletes, they all have coaches. Just because they're making millions and they're the top player, that doesn't mean they do things on their own. And so, I think if you're looking to build new skills or do something new, we should really ask for help.

John: All right. That's excellent advice in fact, but I do have one last question, kind of along these lines. Knowing what you know about the industry that you're in, does it seem like right now there's still a lot of jobs out there for physicians who might have an interest the way you do?

Dr. Melissa Choi: Absolutely. I think with where the economy is in general, right now, here we are in 2023, things have slowed down a little bit and maybe they're not doing as many vaccine trials, for example, as they were in 2020, 2021 when COVID was really big. So there have been some ebbs and flows, but I think we're always going to be in need of new treatment options and there's always going to be a need for new trials. And so, it might take a little bit longer than what your plan is expecting, but the jobs will always be there.

John: And it doesn't require a master's degree in research or a PhD in some esoteric area from what you're telling me today.

Dr. Melissa Choi: Absolutely not. Like I said, I wasn't even really sure what a PI did in this aspect at a clinical research site until I was interviewing for this role. So, even if you don't know anything about it, read about it, learn about it. I'm happy to talk to folks about it if they'd like. And I think that there's a place for pretty much anyone in any specialty.

John: Excellent. I really appreciate the time you've taken today. And yeah, we didn't mention that sometimes people do want to get in touch. So, as we spoke about before we got on the call here with the recording that you're on LinkedIn obviously, and that might be probably the easiest way to get in touch with you if they have questions about anything you discuss today and that sort of thing.

Dr. Melissa Choi: Absolutely.

John: Okay, Melissa, thank you very much. I found it very interesting and informative. I've learned myself a little bit more about how to understand how this whole industry works, so I greatly appreciate that. And with that, I will say goodbye until next time.

Dr. Melissa Choi: Thank you so much for having me on, John. It was great.

John: You're welcome. Bye-bye.

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How Does a Physician Land a Pharma Clinical Development Job? – 214

John Jurica — Tue, 21 Sep 2021 09:30:52 +0000

Interview with Dr. Laura McKain

Today on the podcast you will learn how to pursue a clinical development job.

Our guest, Dr. Laura McKain, is a board-certified physician with more than ten years of pharmaceutical industry experience.

She has managed clinical-regulatory strategy, study design, protocol writing, Phase 2, 3, and 4 clinical trials, medical monitoring, safety surveillance, data analysis, and report writing.

Our Sponsor

We're proud to have the University of Tennessee Physician Executive MBA Program, offered by the Haslam College of Business, as the sponsor of this podcast.

The UT PEMBA is the longest-running, and most highly respected physician-only MBA in the country. It has over 700 graduates. And, the program only takes one year to complete.

From Clinical Medicine to Clinical Development

Laura received her medical degree from Georgetown University in Washington, DC. Then, she completed her training in obstetrics and gynecology at Virginia Commonwealth University in Richmond, Virginia. She was in private practice for over twelve years where her clinical interests included well-women care, contraception, HPV, menopause management, as well as general and high-risk obstetrics.

Anybody that feels miserable and trapped… You may feel like you have no options but, I promise you, you have a thousand different options. – Dr. Laura McKain

Subsequently, Laura transitioned her career to the pharmaceutical industry. There she was involved in clinical development projects encompassing a broad range of therapeutic areas. As a result, she brought two new therapeutics to market.

Finding a Clinical Development Job

She is a career coach and resumé expert at mckainconsulting.com. And, she is the founder of the Physician Nonclinical Career Hunters Facebook Group. Opened 5 years ago, it now serves over 17,000 members. It is the premier group to connect with other physicians, find job openings, and obtain valuable advice and mentorship about nonclinical careers.

During our interview, she described the tactics she recommends for finding a clinical development job. She also defines job descriptions used in the pharma industry, and which jobs are the easiest to land.

Summary

NOTE: Look below for a transcript of today's episode.

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Today's PNC Podcast Transcript

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Transcription PNC Podcast Episode 214

How Does a Physician Land a Pharma Clinical Development Job?

John: Today on the podcast I really hope to bring more clarity to the issue of jobs and pharma, particularly those in clinical development. My guest today is definitely an expert in this topic. She's a physician coach. She's a resume consultant or expert, whatever you want to call it. And she's also the founder of The Physician Nonclinical Career Hunters Facebook group, which I think most of you know about. Dr. Laura McKain, hello, and welcome to the podcast.

Dr. Laura McKain: Hi John. What a great pleasure to finally be here with you today.

John: I know. We've known each other for quite a while and it's like, why have we not been able to get together on this thing? But it just happens that way sometimes. Yeah, I've been really looking forward to talking to you, and my listeners probably know this, but you have so many areas of expertise and you've been doing this for so long. It's not just the pharma part, but the helping physician's part that I'm already going to put a bug in your ear about coming back on the podcast to cover another topic sometime in the future.

But we're going to really pick your brain today. First thing we need to do is just learn a little bit more about you. I have a separate intro that I did, but give us high points of your background and your career and what you're doing now.

Dr. Laura McKain: Absolutely. I'm a board-certified obstetrician gynecologist. I practiced in private practice for 12 years before transitioning over to pharma more than 13 years ago actually. I worked first in a couple of contract research organizations. And then I took a big leap and moved over to a startup biotech company on the west coast. Actually, I just recently retired from that company, after my drug got approved. I'm just tremendously passionate about my own career. Actually, I think I've had two careers, as well as my career transition from clinical medicine. And I am just incredibly passionate about assisting other physicians to make sure that they're really satisfied in their professional life.

John: That's fantastic. There has been such a demand over the last few years. And I don't know about you, I assume you've seen the same thing, but it was sort of something that people didn't ever talk about or didn't know about until now there are just physicians all over the place, including in the Facebook group looking for help and making the transition. That maybe doesn't bode well for the practice of medicine and all the hardships that are driving that, but it's definitely something that's growing.

Dr. Laura McKain: I absolutely agree. And I'm hoping that physicians can find perhaps other ways to find work-life balance without necessarily completely leaving clinical medicine.

John: Yeah. I think we talked a lot about making a transition, but always building it on that background in medicine, the knowledge of healthcare. Pharma is an awesome place to do that in my opinion. I've never worked in pharma, but we've interviewed MSLs and medical monitors and others, but really have had minimal exposure to the topic I hope to talk to you about today, which is clinical development or drug development. Tell me a little bit about what is that? I think we have our own understanding about it. It has to do with bringing drugs to market, but tell us what clinical development is as a division in pharma and what it does.

Dr. Laura McKain: Absolutely. Clinical development truly it's a blanket term that is used to define the entire process of bringing a new drug or a device to the market. It includes everything from the folks in the lab that are doing drug discovery, actually looking for molecules that might work, to the folks that are in product development, including the preclinical research, that may be done in microorganisms or in animals to early-stage clinical development where people are doing first in human studies to the later phases of clinical development, which involved the large clinical trials on humans that lead more directly to approval of a new drug. It's a broad range and there are actually a lot of different roles for physicians across clinical development.

John: Now, when I think about physicians in clinical development, I think about those maybe who went directly into academics, or they were doing research as part of their training. But what I think you and I tend to run into are physicians who have already been in practice for a while, they're thinking of leaving and now they want to transition back into some aspects. Maybe give us a little bit more of an idea of what jobs are in there that would be the most appropriate for physicians looking to go from clinical into that division of work.

Dr. Laura McKain: I think there are a lot of options and some of them may actually be things that physicians haven't even really thought about, particularly ones that still actually rely upon a lot of physician's clinical skills. One of them to start out with, and I'm going to start before a physician actually becomes employed by either a contract research organization or actual pharma company is to be a principal investigator in clinical trials. While you're still interacting with patients, it's very different than having a sick patient come to you for an answer.

When you're a clinical investigator, you're actually conducting industry sponsored clinical trials that are aimed toward getting a drug approved. And it is a fabulous role for somebody who feels like they have no experience in pharma or they feel like they don't have anything that they could put on a resume to get them their foot in the door with pharma. It's a great way for physicians to work on building that book of experience to make that transition.

And there are a lot of different settings for principal investigators that they can use their skills and to build this experience. For instance, they could work for actually large phase one units, which there are many across the country, where you're actually a full-time employee and you are enrolling patients, oftentimes, folks who are participating first in man trials, or they are doing studies like pharmacokinetic studies, to understand how new drugs are metabolized. Many of these types of facilities are actually inpatient facilities because they sometimes need to keep the patients for days in order to do the needed studies on them. They love employing emergency medicine physicians in this role, because again, it's a first demand drug. So, it's a great use of skills.

But there are also a lot of freestanding dedicated research sites that are either privately held or that a lot of physicians develop on their own to do later phase clinical trials. Think about like "Where did all of our trials that got us COVID 19 vaccines come from?" They were not done at academic institutions. Some of them definitely were done at academic institutions, but a lot of them were done in freestanding clinical research sites with principal investigators that were family practice docs or internists or from other specialties.

John: Okay. I'm going to dig into this a little bit, just to clarify for me and the listeners. Let me just give an example. I'm at a hospital where I was a CMO and we had an IRB and I sat on the IRB and we had these protocols come through. Most of those were external. And then we had people that were on staff at the hospital as part of that study, but would they be called a principal investigator or they would be an actual site from a study that was being produced either by the company directly or a CRO? How does that work?

Dr. Laura McKain: It really kind of depends upon how things are contracted, but you're right. Some physicians who are acting as a principal investigator, they may use their local institutional review board, the IRB, the committee that's required to review protocols to ensure that they are appropriate for patients. They may use a local IRB to conduct this research, but something that you may not know is that there are a lot of what we call central institutional review boards. IRB is that free standing units, not associated in any way with a hospital or an academic institution will use as their approval body for conducting this research.

Again, it really varies. There are some physicians that even act as a principal investigator within their own practice. They use a central IRB to get that approved. And they do it just part time. I've conducted many studies with lots of investigators who have that sort of setup. And then some of them love it so much they transitioned more and more away from actually seeing regular care patients and move toward doing clinical research on a full-time basis.

So, there are a lot of different settings where clinical research gets done. Academic institutions, hospitals, privately held investigational sites and then mom and pop organizations that physicians have started on their own.

John: All right. I hope I wasn't confusing anyone that's listening about the IRB. I think our IRB when we were involved with, let's say a national study and we happened to be at site, we were more just monitoring it. And there was a central IRB that approved the overall protocol, but we might have an oncologist on staff who was just enrolling patients into a study or urologist. I think he was more involved with procedures or in ortho doing certain implants. So, that did give them an exposure. And I didn't personally know anyone that used that and went into more of a full-time, but you're saying that's definitely a segue where you can say, "Look, I've been doing these studies, I've been monitoring patients. And so, why not do that full-time or something like that?"

Dr. Laura McKain: Absolutely. I've worked with lots of folks that have been principal investigators for industry sponsored research, and have used that as leverage to get a job with a pharma company. Absolutely. It's a great way because you already know how protocols work. You know so much that you would need to be able to know from the other side to be a medical monitor or what have you.

John: Would those people look at the firms, the companies that they were helping with their own study, or they look somewhere else? They say, "Look, I've got this experience in oncology" as the easiest way to use the company that they're already affiliated with, or could they just go to a CRO or some other company?

Dr. Laura McKain: Oncology is kind of a separate beast in terms of clinical development. Let's kind of just set that aside because a lot of oncologists, as part of their regular practice, do offer their patients the opportunity oftentimes last-ditch effort to enroll in study. So that's a little bit different. Let's talk about developing a new diabetes drug, or as I said, a vaccine. I did women's health studies. Those spokes are how they get their studies, how they find them really varies. Generally, some of them begin because they have relationships with contract research organizations, or they may work through what's called an SMO - Site Management Organization who helps them to find studies. And then there are some people who have just been doing it for so long that the companies come to them when they have a potential study. So, there are a variety of different ways here.

John: Okay. I guess that brings me to the question then, how would a physician other than being involved in something like that position themselves to move into pharma more directly? Are there things they can do beyond that that would help bolster their resume? What kind of suggestions would you have for that?

Dr. Laura McKain: You mean beyond being a principal investigator?

John: Yes. Or instead of if they haven't happened to be a principal investigator.

Dr. Laura McKain: I think there are a number of things that physicians can do to demonstrate that they have an understanding of how clinical trials work and what the work that they may be doing at a contract research organization or a pharma company. It definitely helps if you've got some clinical research experience but it could be something just as simple as being a real supporter of clinical research and being somebody who refers your patients to potential clinical trials. Getting great familiarity with clinical trials through that sort of pathway. So, physicians, let's say gastroenterologist. They have patients who have Crohn's disease which is very difficult to treat and they haven't found the right drug. They may help their patients find clinical trials to enroll in to offer them other potential options for successful treatment. That's definitely one way.

Other ways if you're a physician and you have absolutely no experience, would be to do a lot of reading, quite frankly. Really pay attention when new drugs are getting approved. Really look at sort of what the end product of new drug approvals are. And specifically, that's the prescribing information. Those long little leaflets that come that come with the drug. They're like 27 pages long. That's the end result of a clinical development project and really understanding what's in those documents and studying those sorts of documents and understanding the lingo and how they get to it. Looking at the published trials that come from new drug development, the pivotal phase three trials that are submitted as part of the new drug application.

Just getting that education and being well versed in it, being able to speak about it is great. If you're involved with drug reps at all, getting the word out that you're potentially an early adopter of a particular product and asking to speak with your regional medical science liaison to develop relationships with an MSL, to maybe get on a speaker's bureau for a drug. Actually, that was one of the ways that I got into the industry. I had been part of a number of speakers' bureaus for products that I really, really, really believed in. And that counted for me as being industry experienced, believe it or not.

I think another important thing is to potentially become a key opinion leader in your area. Choose some niche in your practice, something that's really of interest. Particularly, it's kind of nice if it's something where they're doing ongoing research. And become an expert. You should be the person that people refer patients to, have passion for it, really specialize in it.

And then last, but certainly not least what I always say is you should be networking. You should be networking. You should find people in the industry, find out what they do, do informational interviews with them, et cetera, et cetera. And those sorts of experiences can help you get your foot in the door with either a contract research organization or with a pharma company.

John: Does it seem like one works better than the other in terms of a CRO versus directly with a pharma company or does it just depend?

Dr. Laura McKain: I think there are certain specialties that can leap over to pharma much more easily. We already mentioned it, oncologists. If you're an oncologist out there listening, getting a job in pharma, it's as easy as falling off a log. I'm exaggerating, I know I'm exaggerating, but there are some specialties that are in tremendous domains. There are other specialties that I think have a much more difficult time. I've worked with a couple of folks like radiologists. I have really had a hard time trying to find an avenue for radiologists to get in. I'm not saying it's impossible because I know radiologists who've worked in clinical development, but it's probably a little bit more tough. Although even with that, there are angles for their careers.

We're kind of getting off on a tangent here, but there are companies that provide services to clinical trials, where they do very standardized assessments of certain diagnostic studies. A radiologist could go to work for one of these companies that does what we call "centralized readings" to make sure everyone's x-rays or what have you gets read in exactly the same way using exactly the same criteria. And I've worked with many radiologists who've gotten into that business. So, there are a lot of different avenues. There are lots of possibilities depending upon your specialty. Nothing's really off the table.

John: Very interesting. It can be overwhelming in a way. But you mentioned the KOL or key opinion leader and influencers and so forth. I mean, that's kind of the jargon they've heard from MSLs for example, and I'm sure there's a lot of other jargon. So, what about the titles themselves? What would be the jobs that a physician is looking at getting? Is it a medical director position? Is it a clinical scientist? If they're just trying to look around now, maybe look on Indeed or LinkedIn or somewhere just to look at a job description, what should they look up if they're looking for that kind of a job at a CRO or a pharma company?

Dr. Laura McKain: Sure. It does depend upon how much experience you have and where you might need to aim if you're looking to work for a contract research organization or for a pharma company.

I would say that generally speaking, a board-certified licensed physician who's looking to make this transition but maybe you don't have a lot of experience. I think a safe job title to pull up is an associate medical director position. And if you're entering it into LinkedIn, I put "Associate medical director clinical development", very specifically to look for those sorts of jobs. At a contract research organization, you're that type of role. You're really going to be serving as what we call a medical monitor.

It's actually not very common to find jobs titled as medical monitors. You can find them, but they're less common. Typically, the overarching term is an associate medical director or a medical director. But you would be performing that sort of role. You would be monitoring clinical trials, providing medical oversight to clinical trials in an associate medical director role in clinical development.

Going up the food chain from their medical director, senior medical director, executive medical director, some companies do or do not have this would lead them into a VP role. And then ultimately to a chief medical officer role. Obviously, those are all demanding experiences, but associate medical director is a good place to start.

For some people, even that may be kind of too high to aim. And another role that you can look for is a role as what's called a clinical scientist. And you can find those at pharma companies and also some contract research organizations. A clinical scientist is kind of the right hand to the medical monitor on a clinical trial. They still need to have a lot of clinical experience. They need to be very familiar and know a lot clinically to be able to review data.

They will play supportive roles to medical monitors, particularly on really high-volume studies. Again, I keep going back to our recent example of, "How did we get these COVID vaccines?" I guarantee there was like an army of clinical scientists out there that were helping to monitor the data, and to summarize it for the applications which got us emergency use authorization.

But clinical scientist is a great entry role. You'll find some physicians in that role, you'll find potentially foreign ex-US trained physicians in that role, but you'll also find PharmDs and even PhDs in that role. But it can be a potential place to get your foot in the door.

And then let's talk about the person who perhaps graduated medical school, but didn't do a residency or somebody who didn't complete a residency, or again, I'll even go back to somebody who graduated or trained outside of the US who's never been licensed here.

You talk enough about this, or we don't talk enough about that group of people, but there are roles in clinical development for those folks also. And I have worked with many people with the background that I've just described who serve as a role as a clinical research associate. And they often work for contract research organizations and they are fully trained on clinical trial protocols. And they actually go to the sites that are conducting the research. I'm really simplifying this, but they ensure that the data has integrity, that it's not fraudulent data, that it's been entered into the database correctly, that the site has conducted the study according to the protocol, with like I said, great integrity and they reported everything that they need to report.

Those clinical research associate roles are extraordinarily important. They definitely require a great medical background. I often see nurses in that role, other paramedical people in that role, but I've also, like I said, I've seen foreign trained MDs in that role. And it can be a foot in the door for pharma.

I built a drug safety team at one of the companies that I worked at. And I actually promoted a couple of people who had served as CRA's clinical research associates to drug safety physicians because they had all the medical know-how and they knew about clinical trials and they were great people to promote up to a more traditional physician role. So, there are lots of opportunities out there.

John: Oh, that's very helpful. I don't want to digress too much, but you mentioned this person, just this last bit here, that they were promoted into a safety role. This is just because in my mind, I'm trying to keep the parts of a pharma in my head and I tend to break them down into sections. So, I kind of think of the safety as standing by itself. It's not really part of clinical development. I don't think it's part of medical affairs. It doesn't kind of straddle all those things because it's maintaining safety.

Dr. Laura McKain: It does. Think about the role that safety plays in clinical development. When a company is developing a drug, there are two things that they are trying to establish. They're trying to establish the efficacy of the drug and also the safety of the drug. If the drug isn't safe, it doesn't matter if it's effective or not. You can't approve it. The pharmacovigilance department, the drug safety folks played an enormous role in clinical development.

And in fact, the clinical development people work very closely with the safety folks. And there is a ton of communication that goes on between the two groups. They review and analyze data together. Although the clinical development people are responsible for collecting the data, the pharmacovigilance people are really important in terms of meeting the regulatory requirements during development, but also, they play a huge role in the development of the actual applications when they go in. There is a ton of overlap.

And I'll tell you, John, that folks who work at contract research organizations, their positions that they get as a medical director are oftentimes really hybrid positions where they are responsible for medical monitoring, but they also can play a huge role in safety and they get very well versed in the regulatory requirements about both of those.

Of course, it's my experience, but I think contract research organizations are an amazing learning field for physicians who want to get into industry because you really get a broad view of things and you get to work with a bunch of different pharma companies to see how things are done differently at different companies. And it makes it much easier I believe to go onto pharma from there.

John: That is very helpful because we need to know how to get our first job. That's the hardest part I think from what I understand. Once you're in, then you can look around, you can continue to grow and learn and maybe shift. I just want to summarize things here though. I want to go back to the beginning. I'm in a position where

I'm thinking about doing something like this, but at the beginning, as you said, do your research, learn as much as you can, network. And I would assume also in some cases like physicians you've helped, get a coach, maybe that can help navigate this with you, if necessary, because it can get very confusing. Are you still doing coaching for physicians at this time?

Dr. Laura McKain: Absolutely, I do. I do work with individual physicians. And I'll be honest, I've really sort of narrowed my focus. I was kind of taking all commerce for a while, but I really have honed in on folks that are more interested in moving into pharma. I work with them to help them really mine their own background, their own experience to find those transferable skills that make them qualified for pharma. But I also can coach them on finding opportunities to build that runway to make the leap over.

John: All right. I do have to put the plug in now. It's at www.mckainconsulting.com.

Dr. Laura McKain: Yes. And check the show notes to make sure you get my last name spelled because it's a tricky one.

John: Right, right. So, that's one way you're helping people. Now, you're also helping them through the Facebook group so we have to spend a few minutes talking about that. Give us the entire history of the Facebook group in two seconds. No, I'm kidding. Just give us an overview of what's going on there.

Dr. Laura McKain: I established it five years ago, really just because of my own passion around this amazing second career that I've had. I really love my clinical career but I just feel like I've had this amazing second career I've gotten to. I've had two drugs that have gotten approved. I've literally traveled the world. I've gone to see how medicine is practiced all over the world. It's really been phenomenal. I just feel really privileged to have been able to do this. And after I got out of clinical medicine, I had lots of physicians, friends, and whatnot coming to me, "How would you do? How would you do it? How would you do it?" And I started the group to try to answer that question. And it has grown extraordinarily organically.

John, you've been an absolutely important administrator for the group for many years that have really helped us to truly grow organically. I mean, the group has sort of grown on its own. I will say. There has not been a lot of effort that's gone towards building it. We're up to almost 17,000 members at this point. We're fortunate that we've got a number of different experts in a variety of nonclinical settings that are really offering expertise to the group.

And then most recently, I made some changes in the group. And now because it's becoming more work to administer the group, we have a number of awesome sponsors for the group. John, you're one of our platinum sponsors for the group because of all of the contributions that you've made. But there have been a couple of individuals and one company that have stepped up to provide a little bit of financial support to kind of keep the thing moving and rolling.

But it's a great place for physicians to come to get exposed to people that are doing a variety of different things, non-clinically, as well as getting advice about navigating a transition. I think more and more our group is also helping to assist physicians who are just really feeling burnt out and maybe transitioning out of medicine isn't the right thing. But I think some of them are all saying they are finding appropriate connections within the group. "Maybe I just need to change my clinical practice and stay". So, I think we're beginning to kind of service that group also.

John: Well, that's good. That's awesome. And you're right. A lot of it is basically just people that are unhappy and they'd need support and they're getting encouragement with all physicians, 100% physicians, obviously. Yeah, I like all the new changes that you've made in the last several months and I think there are more coming. But it's a great place to go if you just don't know where to go, who to ask for advice on how to move into a nonclinical career or something like direct patient primary care or concierge med. All these things that are alternatives to the traditional practice that may be causing your brain to fry physically.

Dr. Laura McKain: A lot of the stressors seem to come from some sort of corporate medicine right now. People really do need to know that there are alternatives there and for anybody out there who's listening that feels miserable and trapped, you have to know that you may feel like you have no options, but I promise you, you have a thousand different options. It just takes some courage to find the thing that'll work for you. It may be something nonclinical, but you know what? I think there is also a great chance that there are answers if you want to stay in clinical medicine. Probably not what you expected me to say today, John.

John: No, no. I have guests on frequently that it's like if you can figure out a way to practice that isn't corporate medicine, because it's just killing you then by all means, do it. I certainly want to have a doctor for myself.

Dr. Laura McKain: Oh, yeah. And there are maybe people that can do things part time. Like I said there are a lot of people who have a clinical practice, but they also act as a principal investigator and that variety in their life makes things more doable for them. There's a lot of different ways to find happiness professionally. And I encourage everyone to do it. Don't wait. This is not a dress rehearsal.

John: Absolutely. I'll put a link to the Facebook group, but if you look up "Physician Nonclinical Careers" or "Nonclinical Careers", you'll find the Facebook group. I would encourage if you're not already a member to join there. There is a little vetting. You have to answer some questions, but if you're a physician, you can join. Is there anything else I'm missing in terms of places we should look for you? I think you're on LinkedIn, for sure.

Dr. Laura McKain: I think that's plenty. I'm in the Facebook group every day, now that I'm retired. Of course, once I've retired, I've got little quotation marks. I'm still doing pharma consulting and some other things, but I'm really doing it on my terms now. But the Facebook group definitely is a place to find me and mckainconsulting.com is another place.

John: All right. Well, it looks like we're about at the end here. Any last bits of advice for the listeners today?

Dr. Laura McKain: The last piece I would say is that if you're really seriously considering transition, I accomplished my transition solo and I don't recommend that. I think that now there are so many more resources and places to go for help. Rather than groping your way in the dark, reach out for help. It's worth it. I swear to you, I'm not trying to sell coaching services. I just hate to see people struggle. There are opportunities for people to get real professional help that can make the process much more efficient.

John: Very good words of wisdom there, reach out for help. And it goes all the way back at the beginning, when you were talking about networking and talking to others and learning. So, that's great. All right, Laura, thank you very much for joining us today. I'm definitely going to hold you to come back again and talk about some other things. So, with that, I'll say goodbye.

Dr. Laura McKain: Bye John. Thank you.

John: You're welcome. Bye-bye.

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The post How Does a Physician Land a Pharma Clinical Development Job? – 214 appeared first on NonClinical Physicians.

Use These Simple Tactics to Land a Fantastic First Pharma Job – 209

John Jurica — Tue, 17 Aug 2021 10:00:09 +0000

Interview with Dr. Marsha Caton

Our guest today shares tested strategies to enable physicians to find their first pharma job.

Dr. Marsha Caton obtained her M.S. in Biology and Ph.D. in Human and Molecular Genetics at the Albert Einstein College of Medicine. She has worked in the pharmaceutical industry for many years. She is an expert in managing NDA submission teams and delivery of regulatory documents for drug approval.

Dr. Caton has expertise in medical writing, medical affairs, pharmacovigilance processes, health authority responses, and regulatory guidelines. Her experience working in pharma runs the gamut from scientific consultant, medical writer, and clinical research associate, to medical affairs specialist and pharmacovigilance scientist.

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Land a Fantastic First Pharma Job in Clinical Development

Pharma is a huge industry, with thousands of physicians working in dozens of job categories. Some of these jobs can be filled by physicians with almost any background and experience if certain strategies are implemented.

Make yourself special on your resumé and make sure you stand out from the pack. – Dr. Marsha Caton

Today we get the perspective of a Ph.D. who has worked in several companies, at different levels. She applies what she has learned to help physicians find their first pharma job in Clinical Development. This is a very challenging but rewarding field to break into. As she points out, however, it can be done with proper planning, networking, and adjustments to your resumé.

Summary

Dr. Caton shared lots of information and useful advice in this interview. If you’re interested in breaking into the Clinical Development division of a pharmaceutical company to land your first pharma job, you will find it invaluable.

NOTE: Look below for a transcript of today's episode.

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Today's PNC Podcast Transcript

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Transcription PNC Podcast Episode 209

Use These Simple Tactics to Land a Fantastic First Pharma Job

Interview with Dr. Marsha Caton

John: Well, I have been desperately looking to find someone who's an expert on careers in the pharmaceutical industry. I've had a couple of guests on, but pharmaceutical companies are so huge. They have so many types of jobs, particularly for physicians that we talk about. I was really happy to be able to meet on LinkedIn today's guest, Dr. Marsha Caton. She is a Ph.D. with experience in multiple jobs at multiple companies. And so, I really appreciate her for coming here today. Welcome to the podcast, Dr. Caton.

Dr. Marsha Caton: Thank you very much for having me. I'm very excited to be here and to talk about something that I love to do and love to see people succeed with.

John: I get questions asked all the time about how to break into a pharma job, particularly from those physicians who did maybe minimal research, had minimal exposure, didn't work in academia, and that sort of thing. So, I'll really be interested to hear what you have to say. But just to help our listeners understand where you're coming from, why don't you tell us a little bit about your educational background and your career so far in terms of what you've done in pharma and elsewhere?

Dr. Marsha Caton: Thank you for that. I have a Ph.D. in human molecular genetics. I went to Albert Einstein College of medicine. And after completing my Ph.D. really decided that I wanted something a little bit different from bench research, which I'm sure a lot of physicians can somewhat identify with. With getting to the end of the road and saying, "Hmm, I wonder if I would like to try something a little different". Most PhDs do go into bench research. I think now it's becoming a little more acceptable to not go into a postdoctoral program and onto running your own lab and research center of some sort.

But at the time I was pretty much an outlier and decided that I was going to chart a different course. That course really wasn't very apparent to me because nobody really talked about what you can do outside of becoming a tenure track professor, but with some research and a little bit of persistence in the job market, I was able to break into pharma.

My first role was in medical affairs. And then I had gone into, benefit risk management, into pharmacovigilance or safety reporting and then finally into medical writing. So, those are the different roles that I have held, each having a little bit of a different emphasis, but I wouldn't have it any other way.

John: Now with that experience in addition, you do a little bit of mentoring coaching from what I understand. Maybe you can tell us a little bit about that.

Dr. Marsha Caton: Absolutely. That has been something that sort of found me. I was there on LinkedIn, minding my own business, and a lot of people, PhDs and MDs would reach out to me to find out more about what I did in the industry. How I broke in was the most frequently asked question. How did you get in? Because I've been applying for two or three years, and I have no idea why I'm not getting any responses. I don't know what I'm doing wrong. I've tried all the companies, all the biotech's, all the CROs, is usually what I hear and still nothing.

Initially this started off as me just having conversations with people who I had never met, who just wanted a little bit of help. And so, I began to help those people as much as I could. And then they started sending their colleagues to me. And so, that's how my consulting opportunities really found me as I said.

John: Well, I think it shows that there's probably a huge demand for helping people with this problem. Particularly I have three groups of physicians that tend to ask me questions and that follow the podcast and other things. It's usually someone who's been out in practice for 5 or 10 years who is either burned out or they're just getting tired of clinical practice, and wants to try something different.

Then there's those that contact me that don't have residency training. They may have an MDD or maybe an MBBS or equivalent. And for whatever reason, either they couldn't get a residency or they just chose not to do it. And then occasionally I even had this question. I had a resident ask me the other day thinking "I don't think I want to practice when I get done, but I would love to go do some research in a pharmaceutical company". And he was a psychiatrist, I think. Having said all of that, I'm going to let you kind of talk about what kind of jobs would each of those groups tend to be most likely to transition to in your opinion.

Dr. Marsha Caton: I've had all of the above reach out to me. And I usually start out by getting the conversation about what's really important to you. And most often I hear, "Well, the quality of life and not spending 80 hours a week in the clinic" and that sort of thing. And then from there, we move on to what kind of role do you see yourself in? And most people are really not aware of the types of roles that are in pharma for physicians and scientists or physician-scientists. And there are several.

I don't think there's really a limit, but I think you tend to see a concentration in a few roles. So, there's the clinical director role. And that role is really involved in driving the execution of the study, looking at the science interfacing with the clinical sites. The PIs at the clinical sites, I would say. And really driving the clinical development program forward for a particular compound and indication. You might have whatever indication there is, vaccines or oncology. And a clinical director might have a portfolio that he or she is responsible for, making sure the execution is there for those particular compounds or drugs.

And then there is the medical monitor who really looks at the safety aspects of the study. There is also the pharmacovigilance or the safety physician, which looks at the safety of the program. So, a bit higher level than the medical monitor. The medical monitor is involved in the day-to-day communication with the sites about adverse effects that are being observed and keeping a pulse on the safety of the compound. Whereas the pharmacovigilance department or physician is really overseeing and sometimes looking at signals and the overall safety profile for the drug.

And then there are a fair number of physicians who are involved in regulatory sciences. And so, they are really invested in knowing the industry regulations, whether it be the FDA or the EMA or Health Canada, or PMDA in Japan. They are really abreast of the regulations. And so, it's where the science meets the clinical meets the regulatory.

Those are some of the major buckets, but there are roles across the organization that physicians, scientists, or physician-scientists can find a home in. And there's also medical affairs, which is another huge realm for physicians as well. And they are really involved in the commercialization aspect, not sales, but commercialization in terms of making sure the clinical information is disseminated to the sites and the advocacy groups. And it gets out into the marketplace. They are really involved in the education and making sure that the clinical information for the drug is well-positioned in the marketplace.

John: There's a lot of options there, aren't there? And we could dig into each one, but I'll avoid that for the moment. Let me ask you the question from this perspective. Let's talk about the clinicians that may be in practice. Now, I think it's one thing for maybe an oncologist who maybe has been involved in studies as a side over the years. It would seem that person would probably have an easier time converting to something in clinical development than let's say someone who's just been practicing privately and not been involved in any studies.

But is there a background that a physician, a practicing physician, whether an internist or ER doc or whatever that you could think of that would enable them to get into either the clinical development or maybe some other aspect? And I'm thinking of things like, I mean, we had an IRB, we had people that were on that IRB for years, and they really understood looking at studies, at least. They had that. Or maybe they did research in undergrad or at a master's level for something even before they went to med school. What do you think about those scenarios?

Dr. Marsha Caton: Right. I think those are all helpful in getting yourself noticed in the candidate pool because the pool is huge, right? There are people from all over the world who are applying for these roles sometimes. For someone who's in internal medicine or so, if they've written any textbook chapters, if they had any exposure to clinical research in the past, whether it be from taking a good clinical practice course or understanding say international codes for harmonization.

Various things. There are ways that people can get exposure to the world of clinical research. If there is no prior clinical research, I usually strongly encourage people to look into small certificates that at least begin to demonstrate that you have some familiarity with the field.

And some of these are not extensive. Some of these can be free. There is a whole list of organizations and places where you can go to get some kind of certification. And most times we're talking three to six months in time investment just to get your feet wet into the world of clinical research.

As you and I chatted about before, medical writing is a great way for physicians to get into clinical research and into pharma because it really exposes them to the full gamut of the deliverables. The deliverables being the end products of all of this research. So, you have this compound and you have a program to test it in a particular subset of patients, and you do all of that. And that culminates in several deliverables that are submitted to the agency, and that's where regulatory medical writing comes in. And so, I have had a few physicians. I can think of one who had a little more exposure and one who really had very little exposure to clinical research. And so, I connected them with someone in my network to get exposure to medical writing. And they both eventually landed industry jobs, using that method.

John: Okay. Can you tell me more about that? Medical writing when we look at it, we've had guests talk about that. It goes everything from journalistic writing for the public to CME and education for the public to other things. But we often also hear about this regulatory technical side and I even had a guest once who was doing freelance medical writing and moral journalism, and then she ended up being hired by a CRO to do more technical work. So, tell us a little bit more about the kind of writing we might look to do and how to get into that writing as a way to step into pharma since we're talking about it.

Dr. Marsha Caton: Sure, absolutely. So, my area of expertise is not the journalistic, CME, that sort of thing writing. I am really specifically in regulatory writing. And so, regulatory writing is very different from the writing that you would do for medical affairs, where you're writing a publication or CME materials, slide decks, that sort of thing, posters, abstracts. Very, very different.

Regulatory writing is really a highly regulated environment that really follows very specific guidelines laid down by the FDA, and other foreign regulators that really prescribe how data needs to be presented. There are rules that ensure the robustness of the data, that ensure the safety and efficacy are there. And so, there are oodles and oodles for lack of a better word, lots of, lots of regulations about how these data is to be presented. And so, regulatory writing is really focused on making sure you present your data within the framework that is prescribed by these regulatory agencies, by the FDA or the EMA.

And so, it's its own skill. It's really high science. There is a lot of clinical input that goes into that. But what is required for that is really a strong understanding of the science and an understanding of the regulations, and framing that in a clinical context. So, it's a very interesting intersection in the pharmaceutical industry, but it's one that is in high demand. And it's an area of increasing importance as the regulations get more and more stringent for demonstrating relevance in the industry for the irrelevance of your data, right? It's one that's becoming of increasing importance because understanding the regulations and what the FDA or EMA would like to see, and then how you position that, understanding the science and understanding the competitive landscape, what are your competitor products and how do you compare against those? That's one segment of what one needs to understand. And the other segment is the mechanism of action of the drug and what you see in the patient is really connected to the mechanism of action. Everything is not cut and dry. So, the science becomes a big interplay there with the clinical.

John: How might one get some experience or start to understand the regulations? Some of us are exposed to it, of course in our practice, some of us, like I said, if we're working and doing a study maybe as a site for a larger study or even an IRB, we're looking at studies. Some of us may have had the opportunity to write articles, be an author for some clinical study, not a pharmaceutical drug study or something like that, a phase three or something, but actually just some research. And so, how would we try to pull that together?

Dr. Marsha Caton: Well, first of all, there are international guidelines that govern regulatory writing. In the industry, we refer to them as ICH guidelines, which stands for the International Council for Harmonization. And that is based on lots and lots of conglomerate ideas about the way documents are written should be consistent regardless of the region of the world that you're submitting to. So those are the basic set of guidelines. And then you can layer on top of that FDA guidelines and then and or EMA guidelines. That's where the familiarity comes, and looking at those regulations and really having a thorough understanding of them.

If I had to say the easiest way to get some experience. "Easy" is relative here, but the easiest way to get some experience with regulatory writing would probably be through looking at CROs. Just because with big pharma is usually a requirement for prior experience doing that. For the couple of physicians that I steer towards medical writing like I said, I connected them within my network, with the contacts who had freelance regulatory writing businesses. And so, that's a much lower bar than even getting hired at a CRO or getting hired at a pharma company, which is I wouldn't say impossible but challenging. That is the route that I have taken with some of my clients.

John: Well, that makes perfect sense. We've seen this in other fields, I don't know, UM and other things. There are firms like a CRO, that's a middleman and they will hire their own doing this thing, but then they'll also do freelancers and temporary and so forth. So, the CRO, I think, from what you're saying, hire sometimes to fill in those gaps or freelance writers to do the regulatory work. So that, like you said, might be the lowest bar for someone looking to make that switch. And believe me, it's not quick. I have people that are saying, "Well, should I take three years and get an MBA to change my career?" Some of them are pretty, not desperate, but they're willing to do almost anything to move out of clinical medicine sometimes.

Dr. Marsha Caton: One of the women physicians that I've worked with, she was in the process of doing her MBA, and actually ended up landing a job while she was doing the MBA. So, I would say the MBA is not absolutely necessary. You can't go wrong with an MBA, don't get me wrong. Regardless of whether you use it when you're starting or whether it's down the road, I think the value of that, everybody knows the value of the MBA.

But in terms of the industry, I would say that it is not absolutely necessary unless you really want to end up in the business side, leading a business or a franchise. I would say you could probably forego that if you amassed the right kind of experience with clinical research. But that really takes knowing where to go, knowing who to talk to, and being exposed in the right context.

I've seen courses out there and I've looked at the courses and there are courses, say for medical writing even. It's like, well, it could be made out to be more than it really is in some instances when you look at the courses because I'm sure your audience can identify the way to learn to do surgery is not to read about doing surgery. It's to do surgery. It's to pick up the scalpel and do the thing. It's not to sit and read 29 textbooks about what to do.

And so, sometimes you have courses that may say, "I can teach you all about it", but you're not actually doing the thing in real-time. And so, it's really about getting the right kind of experience that communicates to potential employers. That, "Hey, yes, I actually have exposure to this. I actually understand what the different documents are. I understand what the clinical summary of safety is. I understand what a clinical summary of efficacy is. And these are the things that you have to provide to these agencies, summaries of the efficacy of your drug, summaries of safety, and what the studies look like and demonstrating when you sit in front of an employer, that you understand what clinical research is all about". Really no bias.

And I say that, honestly, it's not because I am in regulatory writing, but if you really want to understand what pharma is all about and to begin to develop expertise, there is actually no better way than to be involved with the documents, hands down. It's the equivalent of just being able to see a patient. You can sit at home and read and read and read, but until you see a patient, you're not seeing patients.

And so, in pharma, there are no patients that the employees deal with. You have these documents, that's the embodiment of your research. And so, there's no better way to get that expertise than to really get your hands on these documents, to look at them, to read them, to ask questions about them, to listen to the content being discussed. And all of that is a part of what you get in medical writing.

John: That's very helpful. Well, I'm going to come back to my listener. He has time. He's not quite finished his third year of a four-year residency in psychiatry, and he might be able to get some more exposure. Now he's involved with some clinical studies. These are really more comparing different, let's say, plans of care, which is the best. It's not really involving drugs or pharmaceuticals or medical devices. Are there other types of research that one would be involved with which would be a little more applicable or be more likely to help someone convince that hiring manager or whoever looks at these resumes to pick that up?

Dr. Marsha Caton: Absolutely. When you say clinical research, I could see the effect if this person goes for an interview. Like, "Oh, I've been involved in clinical research". And you're like, "Oh, what types of?" Yeah, not quite. So, it really has to be very relevant. And so, for someone like that, who's just starting, I would say perhaps the best thing to do would be to look, identify clinical sites, and either volunteer time or become a sub-PI or something like that.

One of my first industry gigs was in a research center in the hospital. That was my very first introduction to clinical research. It was just an oncologist. He had a team, he participated in studies with some of the major pharmaceutical companies. And so, he was the PI and he had a whole team around him. And so, that's a great way to get relevant experience in clinical research. Just identify centers in your area, they're all over the country. And so, it can be something as small, and if you're clinical, there are lots of ways that you can volunteer your time. If that's a path that you're really keen on following.

John: I do think that he would probably be able to find some opportunities if he really looked around. I think he's in a pretty big academic center and should be able to find things. It might not pertain directly to his residency, but that's okay. From what I understand, psych residents have a little more time than let's say the surgical resident would have.

Dr. Marsha Caton: Oh, this will be for the benefit of your audience. If you go on clinical trials.gov that'll show you every clinical trial in America. You put in your zip code and you can identify clinical trials in your area quite readily. And it usually has the PI information, name, institution, most times. Sometimes even an email.

But if you have a name, if you have the name of the institution, it's easy to track somebody down from there and say, "Hey, I am so-and-so. And I'm very interested in learning about clinical research and I can come and administer informed consent if I'm well-trained". Very easy tasks that can be done. Informed consents are written on I think, sixth grade or eighth grade level. So, it doesn't take a highly skilled person to do that, but it's a great way for you to find an area for entry into that clinic or into that space.

Just look for ways to volunteer and help. There are sometimes people in those centers who are looking for sub-investigators, and that's also another way to get some experience. There are also now more recently, fellowships to train people to participate in clinical research. Quite a few for underrepresented groups, where they're trying to encourage physicians to get involved in clinical research in underrepresented groups.

Those are all great opportunities to get some insight into the world of clinical research and then all kinds of things. There are fellowships at the FDA and at the NIH. So, all kinds of ways if someone is willing to invest a year or so to get relevant experience, applying for a fellowship. I mean, of course, those are competitive, but people get in, so it's not impossible.

John: Someone's going to get that position. So, it might as well be you. All right, Marsha, this has been great. I try to make sure that if someone has a question or wants to follow up with you, I guess in general, they have a place to go to. So, I'm thinking we're going to go with the LinkedIn profile, which I'll put a link to. Of course, they can just look up your name, but I'll make it as easy as possible if they want to follow up. Any other advice for my listeners before I let you go?

Dr. Marsha Caton: Yes. In addition to getting the relevant experience, there is a definite threshold for making yourself most attractive to an employer, and you can only do that through a resumé unless you happen to know someone who can directly refer you. And even sometimes with direct referrals, it still goes to someone who looks at your resume and says, "Well, I don't know if this is great compared to all the other resumes that I have". And so, there is, there is a definite strategy in terms of positioning oneself. Once you've gotten that experience, making sure it's written up well and clearly displays the clinical research experience.

And there is a method to doing that, evaluating the job description and making sure that you're a good fit. Because I think some of the frustration comes when people apply for things for which they're not the best fit. Definitely, make sure your resume tells the story, it presents you in the best possible light and it highlights the relevant experience that the hiring manager is looking for.

John: And they can usually tell that hopefully from the job description, right? Sometimes we see a mismatch, but they should be able to, at least what's on paper, try to address.

Dr. Marsha Caton: Right. Now, it sounds simple, but I cannot tell you how many people send their resumes to me and I'm looking at them and I'm saying, "Well, I can understand why you haven't gotten any calls back. This resume that looks wonderful does not display how wonderful you are". And it's important for people to understand that pharma is a very, very high-achieving industry. I would say 70% of people in pharma have terminal degrees. So, walking down the street, I might be the only Ph.D. in the room, but when I sign into work, I am one of thousands. Same for the MD or the DVM. Almost everybody has one. So, you're not special in that regard. You have to make yourself special on your resume and make sure you stand out from the pack.

John: No, that's true of a lot of jobs too when you get to that level. I guess we could spend a whole other hour on resumes, but if you could boil it down to one, when looking at these resumes, just one thing, is it just that, that it doesn't stand out, but why does it not stand out? What is missing that really should have been there?

Dr. Marsha Caton: Usually it is the relevant experience jumping out at the employer as soon as you read it. People in pharma are incredibly busy and I interview people all the time. And by the time I've read halfway down the page, I kind of know whether this person has what it takes or not.

John: So, it should be front and center. It should be pretty much on the first page, the middle of the first page, whatever you want to call that, top of the first page. And it's like, okay, here's what the job entails. And you have this experience, which is somewhat transferrable or identically what we need, get that out there. And no 5- or 10-page resumes unless you're looking for some kind of an academic situation.

Dr. Marsha Caton: Correct. Nobody's reading 5 or 10 pages. For physicians, it's really important to identify transferable skills because in the clinical world, that's what people want to see. But in pharma, they want to know that you're a clinician who can handle the science and all of this hospital, that hospital, this clinic. Yes, we know, but that's not what this job is about. So, it's really important to now transform that experience, those experiences I would say, into something that's relevant for clinical research, whether it be writing, data analysis, lots of different things that need to be highlighted to transform that clinical resume into a pharmaceutical ready resume.

John: Very good. I thank you so much for sharing all of this with us. And if anyone's listening and you want to reach out with additional questions, I definitely will go to LinkedIn and look up Dr. Caton today and or down the road. And I guess with that, I will say that we're out of time. So, I'll let you go. Thanks for coming and it has been very insightful.

Dr. Marsha Caton: Thank you so much for having me.

John: All right. Bye-bye.

Dr. Marsha Caton: Bye-bye.

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The post Use These Simple Tactics to Land a Fantastic First Pharma Job – 209 appeared first on NonClinical Physicians.