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.
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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 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 the move to a pharmaceutical 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
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 very popular Facebook Group.
NOTE: Look below for a transcript of today's episode.
Links for Today's Episode:
- Dr. Laura McKain's Website
- Physician Nonclinical Career Hunters Facebook Group
- Use These Simple Tactics to Land a Fantastic First Pharma Job – 209
- How to Find a Job in Pharma That You Love – 184
- How to Claim Your First Job in Industry – 168
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Podcast Editing & Production Services are provided by Oscar Hamilton
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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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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