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.
Links for Today's Episode:
- Dr. Marsha Caton LinkedIn Page
- Association of Clinical Research Professionals (for certification and other resources)
- FDA Guidance Documents
- European Medicines Agency Guidelines
- ClinicalTrials.gov (database of privately and publicly funded clinical studies conducted around the world)
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- How to Find a Job in Pharma That You Love – 184
- How to Shine as a Technical Medical Writer – 155
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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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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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