Presentation by Dr. Nerissa Kreher – 349
In today's episode, we present an excerpt from Dr. Nerissa Kreher's masterclass on securing the best biopharma positions from the 2023 Nonclinical Career Summit.
Dr. Nerissa Kreher is a pediatric endocrinologist and the Chief Medical Officer at a biotech company. She received her medical degree from East Carolina University. She then completed a pediatric residency and pediatric endocrinology fellowship at Indiana University School of Medicine.
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Unveiling New Horizons: Career Transitions in the Biopharma Industry
Dr. Kreher's journey inspires physicians to contemplate career transitions beyond traditional clinical practice. With over 17 years of experience in the biopharma industry, she offers invaluable insights into the diverse pathways available to medical professionals seeking new challenges and opportunities.
Through her narrative, Dr. Kreher illuminates how to leverage clinical expertise in roles ranging from clinical development to patient safety and medical affairs.
Decoding the Biopharma Realm: Contrasts and Considerations
Nerissa highlights the contrasting dynamics between clinical practice and the biopharma industry. She explores the differing hierarchies, teamwork dynamics, and work flexibility, offering her insights for physicians contemplating a career transition to the pharma industry.
These insights will help listeners prepare for their transition from a frustrated clinician to a fulfilling biopharma career.
Summary
Dr. Nerissa Kreher describes how to navigate from clinical medicine to the biopharma industry effectively. Gain insights into diverse career pathways beyond traditional clinical practice, from clinical development to patient safety and medical affairs. Explore new horizons with invaluable guidance from Dr. Kreher.
NOTE: Look below for a transcript of today's episode.
EXCLUSIVE: Get a daily dose of inspiration, information, news, training opportunities, and amusing stories by CLICKING HERE.
Links for Today's Episode:
- Dr. Nerissa Kreher's Website [IndustryMDCoach]
- Landing Your First Pharma Industry Job May Be Easier Than You Think – 311
- Research and Development in Nonclinical Pharma Careers
- Medical Science Liaison Is Still a Fantastic Pharma Job – 261
- Highlight These 5 Experiences to Land Your First Pharma Job – 242
- How Does a Physician Land a Pharma Clinical Development Job? – 214
- Use These Simple Tactics to Land a Fantastic First Pharma Job – 209
- How to Find a Job in Pharma That You Love – 184
- Purchase Your All Action Pass Videos and Bonuses from the 2024 Summit
- Dr. Debra Blaine's Coaching Services
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Transcription PNC Podcast Episode 349
The Best Biopharma Positions For Motivated Practicing Physicians
- Lecture by Dr. Nerissa Kreher
Dr. Nerissa Kreher: I'm really excited to be here, John and Tom, thank you so much for this amazing forum. I've enjoyed participating over the last couple of nights and looking forward to tomorrow night as well. Thanks for the opportunity. I'll be speaking today about career opportunities for physicians in the biopharma industry. And I'll get to a little bit of lingo in just a second.
A little bit of background on me. I have a business called The Pharma IndustryMDCoach, and I help physicians explore and ultimately find a fulfilling career in the biopharma industry and use a step-by-step guide of taking you through the process of a resume, LinkedIn, interviewing, negotiating.
But in addition, I'm a certified life coach. And so I also apply the principles of life coaching to help people dispel imposter phenomenon, lack of confidence, self-doubt. And I'll raise some of those things throughout our conversation tonight.
John asked us to start by giving a little bit of our background. I thought it would be fun to share my story because people often ask, "How did I end up transitioning?" And I have to tell you that it was a bit fortuitous actually, but I'm very grateful that it happened. And I'm 17 years now in the biotech industry.
Of course, medical school, residency, fellowship, I'm a pediatric endocrinologist by training. I got married during medical school, had kids during residency and fellowship. And my husband, he was a year behind me, med-peds, and had practiced, but then decided he wanted to go back and do a sports medicine fellowship. We found ourselves in the situation of this is a match for sports medicine, and I was looking for a real job. And so, we ended up looking in three different cities, obviously ones with large academic centers where I could have a pediatric endocrine job.
I was on a clinical research path. I got my master's in clinical research during my fellowship and really enjoyed seeing my clinical research patients, but I never really enjoyed being in clinic day in and day out. I really was on that clinical research track and that's where my passion was.
Through this, I thought I had a job waiting for me at Mass General Hospital in clinical research. When my husband matched in sports medicine there, I called the program director, division director, and the first words out of her mouth were, "Oh no." That obviously was a bit stressful. They offered me a job, ultimately a job seeing patients 80% of the time.
I'm very grateful that I at least knew that's really not what I wanted and didn't just take the job out of feeling helpless and hopeless. I interviewed around the East Coast as far as Rhode Island and Dartmouth, New Hampshire, still didn't find what I was looking for. And a sales representative from Serono asked if I would give her my resume so she could share it at her company. And some of you may know or not, Serono has a recombinant human growth hormone, which obviously is a pedendo I'm very familiar with.
That landed me my first role in the biotech industry as the medical director in medical affairs. And I truly loved it from day one. I think it really pulled from that forever learner phenotype that many physicians have. I was exposed to so many new things, but also I was an expert in pediatric endocrinology. And so I was able to teach people, but I was also learning from others at the same time.
I'm now 17 years in, I've worked at seven different companies, medical affairs, as well as clinical development. I'm in my third chief medical officer role. I've had the opportunity of doing two public offerings, taking private companies public, and I serve on the board of director of a public biotech company as well.
COVID hit us, I felt like very, very dire straits in the early parts of COVID. I couldn't go and do a shift in an ER. And so my way of helping was to try to start helping some of my colleagues that needed to transition. And that's where the IndustryMDCoach was born from. So, that's my story. You can probably tell I have a lot of energy about our industry and really enjoy helping people understand it. I look forward to any questions at the end of the talk.
I like to compare and contrast a little bit between clinical and the biotech and pharma industry. Before I do that, I will use biotech and pharma and biopharma very interchangeably. It used to be that biotech technically meant something that we made in cells. For example, recombinant human growth hormone is manufactured in live cells. And pharma meant things that are synthetically made.
It's a big mishmash now. So many, many companies are biopharma companies because they do both. Some people actually now sort of refer to pharma as bigger companies and biotech as smaller companies. I think biopharma encapsules our whole industry. But if I use one or the other, I probably really mean biopharma.
In the clinical setting, and I fully admit there are some generalities here, but the physician is pretty high on the totem pole from a decision-making standpoint. I recognize insurance, admin, things also have an impact on that decision-making, but they are relatively high on the totem pole.
In the biotech and pharma industry, the physician may not be the ultimate decision-maker. Even as the chief medical officer, meaning I'm like the top medical officer at the company, I'm very rarely making decisions in a vacuum. I have my CEO, I have my chief operating officer, my chief financial officer. And so, decisions are being made in cross-functional teams all the time. That's one big difference that I think a physician really has to think about as they consider, "Is biotech and pharma the right thing for me?"
Obviously, clinical individual patient care, biopharma, we're caring for groups of patients. Now I actually don't even have an active medical license anymore. So I'm not caring for them, meaning making medical decisions for them, but I'm doing things that impact their medical journey overall. And I work in the rare disease space and I'm also understanding that medical journey and learning from patients. I do have the opportunity to be at patient meetings, have patients come to our office and speak to us, but I'm not doing that day-to-day medical care.
I mentioned cross-functional teamwork. Clearly physicians are working cross-functionally every day, with nurses, with physical therapists, with occupational therapists, we can name lots of them, pharmacists. But they all are generally healthcare providers, or at least in that healthcare provider universe. Whereas the cross-functional teamwork we do in the biopharma industry is much more highly varied. And so, for example, a program team might have a person from manufacturing, a person from regulatory, a person from clinical, an operations person, a program lead who's in charge of timelines, deliverables, a finance person.
And so, we're really working with people who speak very different languages than us. And one of the things you have to learn when you come into the industry are some of these languages so that you can actually communicate effectively with one another. But again, as I said, that was one of the things that I found to be really fun because I wanted to learn new things.
In clinical, the day can be very highly structured. As many of you know, there may be a patient waiting for you tomorrow at 08:30 and you know that they're supposed to be in the room. For those of us in the biopharma industry, I don't have a patient waiting for me. I may very well have an 08:30 in the morning meeting, but if my child is sick and vomiting, that meeting is a very different pressure than the patient waiting in the room. And so, there is more flexibility overall in the biopharma industry.
Now, lots of caveats. You could have a manager that was a dictator-style manager and your flexibility is out the window. But just in generalities, not having sort of that scheduled patient waiting for you makes that very different.
We have key indicators of success. Obviously, we're trying to make bonuses. We're trying to hit our timelines and our goals. Our key indicators of success vary with the function and with seniority. And so typically, the company sets their goals and they filter down through the organization. Whereas in clinical, maybe if you're in academics, it's related to grants or publications, then obviously RVUs are a major measure as well.
Funding pressures might be high. That, of course, might apply more towards the academic group. But in biopharma, we don't have funding pressures. I don't need to get a grant to do the research. The company has a budget to support that.
Those are some compare and contrasts. One, not better than the other, but I like to share them with people so that if they're thinking about a transition, they can start to think about, "Would I like that? Would that be concerning to me? Does that sound really exciting to me?"
I mentioned learning a new language. So I'll move past that one. But I really do encourage people to think about what kinds of learners are they? Do they enjoy new challenges? Do they enjoy or maybe even, sometimes I feel like I get bored if I'm doing the same thing day in and day out. And so this ability to interact with different people helps with that issue of not getting bored.
Again, you're typically not going to be the decision maker. And so when I'm working with a physician that wants to transition, there's this balance of humility and confidence that you have to strike during the interview process. People have stereotypes about doctors. And I think many of us would laugh at the stereotype because we know that for most of us it's not true, but people do think that doctors are know-it-alls. And so when you're looking at being on a cross-functional team, people don't want to work with know-it-alls. So you're balancing that in the interview process, but you also have to balance being confident and showing that you can do this job.
I think it's a lot of fun. One of the perks in my mind, I love to travel and I've had the chance to literally see the world. I've been to Japan, to the country of Georgia, Australia, Europe. Now, some people would say I have no interest in travel, and that's fine too, because there are roles in the pharma industry that have very little travel for physicians too. But for me, this opportunity to really see the world has been great.
I have amazing colleagues. I'm still in touch with people from that first Serono job. I was just at a networking event tonight. And the six degrees of separation, it's way less than that. This industry, people move roles, move companies. And so, you really have an opportunity to meet some really cool people.
And it can be really stressful. We still have timelines. We still have expectations. There are weekends that I'm working because I'm at a conference. There are evenings that I'm working because maybe I'm running a clinical trial in Australia and the times are different. I had a boss one time who said, people think we sit around and drink coffee and eat bonbons. It's not drinking coffee and eating bonbons. But the stress is something in my mind, I have more control over when I do the work. I still have to do the work, but the "when" there's not sort of it waiting for me in a patient room.
So, what are the main roles for physicians in the pharma industry? I break it down into three. These are the three entry level roles. Now, once you get in, really the sky's the limit. Physicians can be CEOs. Physicians can lead business development functions. There are all kinds of opportunities, but those are rare until you get your foot in the door, unless you have some kind of other specialty training like if you were maybe went through a MBA program and came right out into pharma, there might be some other opportunities.
But tonight we'll focus on the three main ones, clinical development, patient safety or pharmacovigilance. And at some companies, they call this drug safety. A lot of names for the same thing. And medical affairs.
In clinical development, the main roles that you're thinking about as you're looking for jobs, clinical scientists and clinical development physician, which is the director level or senior director level. And it goes up from there. Most physicians that are entering are entering in the associate director or director level. That's where I'm pointing most people, and then you can rise from there.
Pharmacovigilance, drug safety, patient safety. Same thing. You're sort of director level in pharmacovigilance. And then medical affairs, again, same thing for the physicians, medical affairs director. And then there's also another thing that many of you have heard of called a medical science liaison. I'm not going to spend much time on that tonight because we have another person that's going to spend a whole lecture on MSLs and she's the right person to do it because she's been an MSL. I've never been an MSL. And so I'm really looking forward to her talk as well.
As we move through those, I'll talk about clinical development first. Clinical development involves all aspects of studying an investigational drug product in humans. So we refer to early phase trials as phase one and phase two and late phase trials as phase three and phase four.
So if you think way, way, way back sometime, probably in medical school, you might've learned about this in one of your courses, but phase one trials are the initial safety trials. These are the first time we're putting drugs into humans. It usually in larger drug populations is in healthy volunteers. In the rare disease world in oncology, it's often patients that we're doing these safety studies in.
Phase two is early proof of concept. So you're still looking at safety. We're always looking at safety, but you're starting to look at proof of concept efficacy. Phase three studies typically are the large phase three. They're randomized double-blind placebo controlled studies that we use for registration or approval of a drug with regulatory agencies.
And then phase four typically is post-marketing. After a drug is approved, companies still are running trials to either follow long-term efficacy or follow long-term safety. And we refer to those as phase four.
That gives you a sense of the sort of large bucket of what clinical development is, but that doesn't really answer your questions, I'm guessing. So, let's dive a little deeper. The clinical development physician at the, again, associate director, director level, when they're coming into pharma, they're going to be involved in clinical development strategy and planning.
We're thinking about not just what does one trial look like, but what does it take to develop the drug all the way from putting it into the first human to getting it approved, whether it's with FDA or EMA, which is the European FDA or the Japanese or the Chinese or whatever it might be, whatever regulatory agency. You're thinking about the whole program.
More detailed responsibilities might include protocol design, where we're focused as the physicians on what are the appropriate inclusion, exclusion criteria, endpoints, safety monitoring. Maybe there's been a safety signal in the tox studies, you need to pull that into the protocol so you can monitor it in humans.
Another big regulatory document called the investigator's brochure, the physician's going to have a lot to say about what's in that document. And then of course, as you generate data, you've got data analysis, presenting data at scientific conferences, highly engaged in regulatory conversations. Going and talking to FDA, going and talking to MHRA in the UK.
Engaging with thought leaders or key opinion leaders, KOLs, to get their input. So I'm a pediatric endocrinologist and I work in the area of neuromuscular disease right now. So I don't know everything about neuromuscular. I need to go and ask the people that do. And so those are my thought leaders or KOLs.
And then I'm interacting with people like clinical operations. Those are the people that actually execute the trials. Regulatory, patient safety, patient advocacy. Again, those cross-functional team members.
I mentioned some of the titles already. Some of the transferable skills would be clinical experience, clinical trial experience. But here it doesn't have to be that you were the PI on a phase three pharma-sponsored randomized double-blind placebo-controlled study. It can be that you participated in research and that can be retrospective as well. Data analysis, publications.
Without clinical research experience, I typically would say to people, clinical development will be the hardest place to enter. But if you have research experience, which many of you do, then there are opportunities to come in through clinical development.
Moving to pharmacovigilance, again, drug or patient safety. This involves all things safety data. Those physicians are really not thinking about the efficacy of the drug. They are focused on safety and they have to understand the whole safety package around the drug from when it was first put into cells and into animals all the way through.
They're focusing on understanding all the available data and trying to assign whether or not there's relatability to a side effect to the drug, but maybe it's related just to the disease that we're trying to treat. And that's where the clinical knowledge comes into the patient safety role.
They have significant interactions with clinical development, with regulatory. I think I had no idea coming into the industry how much safety data we have to send to agencies like the FDA every, not even just year, but there are reports that are required by law that go in and these safety physicians are highly involved in those.
Some of the titles, associate medical director, medical director. And transferable skills here, your clinical experience. You're the one that understands pharmacology. You're the one that understands the actual clinical disease and that understanding is what you bring to the table for a safety role.
Clinical trial experience is a plus, but not a necessity. And if you have any experience as a principal investigator, that's PI or sub investigator where you've had to report safety data, again, that's a plus as well, because you understand the reporting process, but that's something that you can learn in the job. It's really that clinical experience that comes as the transferable skill.
And then moving to medical affairs. I actually find medical affairs to be the more difficult of all three to explain to people, because if I talk to you about a clinical trial protocol, most people can get that safety, but medical affairs is a bit nebulous. The definition is the external scientific medical arm that takes clinical or medical information from the company to external stakeholders, such as those key opinion leaders and patient groups, even more importantly these days. They share that information and they bring information back into the company for us to integrate into our development.
Medical affairs is engaged in the scientific exchange of information with external stakeholders. Those stakeholders might be, as I've said, thought leaders, but healthcare providers generally. It doesn't have to be Professor Smith, who's the best neuromuscular doctor in the whole of the United States. Yes, Dr. Smith is probably important, but the doctors who are treating the neuromuscular patients day in and day out are also very important to me. And I'm using neuromuscular as an example, it could be endocrine, it could be cardiovascular. But getting that information, what do they need from drugs? What is an unmet need? What is not being met appropriately? And again, patients and patient family input as well.
They're sharing that scientific and clinical knowledge and they're gathering that scientific and clinical knowledge. They also are very engaged in teaching. Oftentimes, I'm asked to give a lecture to a group of laboratory colleagues who they understand what they're doing at the bench, but they might not understand the disease they're actually working on and helping them understand it and talking to them about what happens to the patient helps them really understand why they come to work every day. So there's a lot of teaching involved in med affairs.
And you're interacting with a lot of people, clinical, but here may be more commercial colleagues and also regulatory because we are a highly regulated industry and anything we take outside, we have to get approval to do so. Regulatory is an important part as well.
Similar titles, again, I'm going to leave medical science liaisons for tomorrow night, but associate medical director, medical director and transferable skills here, again, that clinical experience. And if you have experience with data analysis, with publications, that can be a really nice addition as well, but again, not absolutely necessary.
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Transcription PNC Podcast Episode 349
The Best Biopharma Positions For Motivated Practicing Physicians
- Lecture by Dr. Nerissa Kreher
Dr. Nerissa Kreher: I'm really excited to be here, John and Tom, thank you so much for this amazing forum. I've enjoyed participating over the last couple of nights and looking forward to tomorrow night as well. Thanks for the opportunity. I'll be speaking today about career opportunities for physicians in the biopharma industry. And I'll get to a little bit of lingo in just a second.
A little bit of background on me. I have a business called The Pharma IndustryMDCoach, and I help physicians explore and ultimately find a fulfilling career in the biopharma industry and use a step-by-step guide of taking you through the process of a resume, LinkedIn, interviewing, negotiating.
But in addition, I'm a certified life coach. And so I also apply the principles of life coaching to help people dispel imposter phenomenon, lack of confidence, self-doubt. And I'll raise some of those things throughout our conversation tonight.
John asked us to start by giving a little bit of our background. I thought it would be fun to share my story because people often ask, "How did I end up transitioning?" And I have to tell you that it was a bit fortuitous actually, but I'm very grateful that it happened. And I'm 17 years now in the biotech industry.
Of course, medical school, residency, fellowship, I'm a pediatric endocrinologist by training. I got married during medical school, had kids during residency and fellowship. And my husband, he was a year behind me, med-peds, and had practiced, but then decided he wanted to go back and do a sports medicine fellowship. We found ourselves in the situation of this is a match for sports medicine, and I was looking for a real job. And so, we ended up looking in three different cities, obviously ones with large academic centers where I could have a pediatric endocrine job.
I was on a clinical research path. I got my master's in clinical research during my fellowship and really enjoyed seeing my clinical research patients, but I never really enjoyed being in clinic day in and day out. I really was on that clinical research track and that's where my passion was.
Through this, I thought I had a job waiting for me at Mass General Hospital in clinical research. When my husband matched in sports medicine there, I called the program director, division director, and the first words out of her mouth were, "Oh no." That obviously was a bit stressful. They offered me a job, ultimately a job seeing patients 80% of the time.
I'm very grateful that I at least knew that's really not what I wanted and didn't just take the job out of feeling helpless and hopeless. I interviewed around the East Coast as far as Rhode Island and Dartmouth, New Hampshire, still didn't find what I was looking for. And a sales representative from Serono asked if I would give her my resume so she could share it at her company. And some of you may know or not, Serono has a recombinant human growth hormone, which obviously is a pedendo I'm very familiar with.
That landed me my first role in the biotech industry as the medical director in medical affairs. And I truly loved it from day one. I think it really pulled from that forever learner phenotype that many physicians have. I was exposed to so many new things, but also I was an expert in pediatric endocrinology. And so I was able to teach people, but I was also learning from others at the same time.
I'm now 17 years in, I've worked at seven different companies, medical affairs, as well as clinical development. I'm in my third chief medical officer role. I've had the opportunity of doing two public offerings, taking private companies public, and I serve on the board of director of a public biotech company as well.
COVID hit us, I felt like very, very dire straits in the early parts of COVID. I couldn't go and do a shift in an ER. And so my way of helping was to try to start helping some of my colleagues that needed to transition. And that's where the IndustryMDCoach was born from. So, that's my story. You can probably tell I have a lot of energy about our industry and really enjoy helping people understand it. I look forward to any questions at the end of the talk.
I like to compare and contrast a little bit between clinical and the biotech and pharma industry. Before I do that, I will use biotech and pharma and biopharma very interchangeably. It used to be that biotech technically meant something that we made in cells. For example, recombinant human growth hormone is manufactured in live cells. And pharma meant things that are synthetically made.
It's a big mishmash now. So many, many companies are biopharma companies because they do both. Some people actually now sort of refer to pharma as bigger companies and biotech as smaller companies. I think biopharma encapsules our whole industry. But if I use one or the other, I probably really mean biopharma.
In the clinical setting, and I fully admit there are some generalities here, but the physician is pretty high on the totem pole from a decision-making standpoint. I recognize insurance, admin, things also have an impact on that decision-making, but they are relatively high on the totem pole.
In the biotech and pharma industry, the physician may not be the ultimate decision-maker. Even as the chief medical officer, meaning I'm like the top medical officer at the company, I'm very rarely making decisions in a vacuum. I have my CEO, I have my chief operating officer, my chief financial officer. And so, decisions are being made in cross-functional teams all the time. That's one big difference that I think a physician really has to think about as they consider, "Is biotech and pharma the right thing for me?"
Obviously, clinical individual patient care, biopharma, we're caring for groups of patients. Now I actually don't even have an active medical license anymore. So I'm not caring for them, meaning making medical decisions for them, but I'm doing things that impact their medical journey overall. And I work in the rare disease space and I'm also understanding that medical journey and learning from patients. I do have the opportunity to be at patient meetings, have patients come to our office and speak to us, but I'm not doing that day-to-day medical care.
I mentioned cross-functional teamwork. Clearly physicians are working cross-functionally every day, with nurses, with physical therapists, with occupational therapists, we can name lots of them, pharmacists. But they all are generally healthcare providers, or at least in that healthcare provider universe. Whereas the cross-functional teamwork we do in the biopharma industry is much more highly varied. And so, for example, a program team might have a person from manufacturing, a person from regulatory, a person from clinical, an operations person, a program lead who's in charge of timelines, deliverables, a finance person.
And so, we're really working with people who speak very different languages than us. And one of the things you have to learn when you come into the industry are some of these languages so that you can actually communicate effectively with one another. But again, as I said, that was one of the things that I found to be really fun because I wanted to learn new things.
In clinical, the day can be very highly structured. As many of you know, there may be a patient waiting for you tomorrow at 08:30 and you know that they're supposed to be in the room. For those of us in the biopharma industry, I don't have a patient waiting for me. I may very well have an 08:30 in the morning meeting, but if my child is sick and vomiting, that meeting is a very different pressure than the patient waiting in the room. And so, there is more flexibility overall in the biopharma industry.
Now, lots of caveats. You could have a manager that was a dictator-style manager and your flexibility is out the window. But just in generalities, not having sort of that scheduled patient waiting for you makes that very different.
We have key indicators of success. Obviously, we're trying to make bonuses. We're trying to hit our timelines and our goals. Our key indicators of success vary with the function and with seniority. And so typically, the company sets their goals and they filter down through the organization. Whereas in clinical, maybe if you're in academics, it's related to grants or publications, then obviously RVUs are a major measure as well.
Funding pressures might be high. That, of course, might apply more towards the academic group. But in biopharma, we don't have funding pressures. I don't need to get a grant to do the research. The company has a budget to support that.
Those are some compare and contrasts. One, not better than the other, but I like to share them with people so that if they're thinking about a transition, they can start to think about, "Would I like that? Would that be concerning to me? Does that sound really exciting to me?"
I mentioned learning a new language. So I'll move past that one. But I really do encourage people to think about what kinds of learners are they? Do they enjoy new challenges? Do they enjoy or maybe even, sometimes I feel like I get bored if I'm doing the same thing day in and day out. And so this ability to interact with different people helps with that issue of not getting bored.
Again, you're typically not going to be the decision maker. And so when I'm working with a physician that wants to transition, there's this balance of humility and confidence that you have to strike during the interview process. People have stereotypes about doctors. And I think many of us would laugh at the stereotype because we know that for most of us it's not true, but people do think that doctors are know-it-alls. And so when you're looking at being on a cross-functional team, people don't want to work with know-it-alls. So you're balancing that in the interview process, but you also have to balance being confident and showing that you can do this job.
I think it's a lot of fun. One of the perks in my mind, I love to travel and I've had the chance to literally see the world. I've been to Japan, to the country of Georgia, Australia, Europe. Now, some people would say I have no interest in travel, and that's fine too, because there are roles in the pharma industry that have very little travel for physicians too. But for me, this opportunity to really see the world has been great.
I have amazing colleagues. I'm still in touch with people from that first Serono job. I was just at a networking event tonight. And the six degrees of separation, it's way less than that. This industry, people move roles, move companies. And so, you really have an opportunity to meet some really cool people.
And it can be really stressful. We still have timelines. We still have expectations. There are weekends that I'm working because I'm at a conference. There are evenings that I'm working because maybe I'm running a clinical trial in Australia and the times are different. I had a boss one time who said, people think we sit around and drink coffee and eat bonbons. It's not drinking coffee and eating bonbons. But the stress is something in my mind, I have more control over when I do the work. I still have to do the work, but the "when" there's not sort of it waiting for me in a patient room.
So, what are the main roles for physicians in the pharma industry? I break it down into three. These are the three entry level roles. Now, once you get in, really the sky's the limit. Physicians can be CEOs. Physicians can lead business development functions. There are all kinds of opportunities, but those are rare until you get your foot in the door, unless you have some kind of other specialty training like if you were maybe went through a MBA program and came right out into pharma, there might be some other opportunities.
But tonight we'll focus on the three main ones, clinical development, patient safety or pharmacovigilance. And at some companies, they call this drug safety. A lot of names for the same thing. And medical affairs.
In clinical development, the main roles that you're thinking about as you're looking for jobs, clinical scientists and clinical development physician, which is the director level or senior director level. And it goes up from there. Most physicians that are entering are entering in the associate director or director level. That's where I'm pointing most people, and then you can rise from there.
Pharmacovigilance, drug safety, patient safety. Same thing. You're sort of director level in pharmacovigilance. And then medical affairs, again, same thing for the physicians, medical affairs director. And then there's also another thing that many of you have heard of called a medical science liaison. I'm not going to spend much time on that tonight because we have another person that's going to spend a whole lecture on MSLs and she's the right person to do it because she's been an MSL. I've never been an MSL. And so I'm really looking forward to her talk as well.
As we move through those, I'll talk about clinical development first. Clinical development involves all aspects of studying an investigational drug product in humans. So we refer to early phase trials as phase one and phase two and late phase trials as phase three and phase four.
So if you think way, way, way back sometime, probably in medical school, you might've learned about this in one of your courses, but phase one trials are the initial safety trials. These are the first time we're putting drugs into humans. It usually in larger drug populations is in healthy volunteers. In the rare disease world in oncology, it's often patients that we're doing these safety studies in.
Phase two is early proof of concept. So you're still looking at safety. We're always looking at safety, but you're starting to look at proof of concept efficacy. Phase three studies typically are the large phase three. They're randomized double-blind placebo controlled studies that we use for registration or approval of a drug with regulatory agencies.
And then phase four typically is post-marketing. After a drug is approved, companies still are running trials to either follow long-term efficacy or follow long-term safety. And we refer to those as phase four.
That gives you a sense of the sort of large bucket of what clinical development is, but that doesn't really answer your questions, I'm guessing. So, let's dive a little deeper. The clinical development physician at the, again, associate director, director level, when they're coming into pharma, they're going to be involved in clinical development strategy and planning.
We're thinking about not just what does one trial look like, but what does it take to develop the drug all the way from putting it into the first human to getting it approved, whether it's with FDA or EMA, which is the European FDA or the Japanese or the Chinese or whatever it might be, whatever regulatory agency. You're thinking about the whole program.
More detailed responsibilities might include protocol design, where we're focused as the physicians on what are the appropriate inclusion, exclusion criteria, endpoints, safety monitoring. Maybe there's been a safety signal in the tox studies, you need to pull that into the protocol so you can monitor it in humans.
Another big regulatory document called the investigator's brochure, the physician's going to have a lot to say about what's in that document. And then of course, as you generate data, you've got data analysis, presenting data at scientific conferences, highly engaged in regulatory conversations. Going and talking to FDA, going and talking to MHRA in the UK.
Engaging with thought leaders or key opinion leaders, KOLs, to get their input. So I'm a pediatric endocrinologist and I work in the area of neuromuscular disease right now. So I don't know everything about neuromuscular. I need to go and ask the people that do. And so those are my thought leaders or KOLs.
And then I'm interacting with people like clinical operations. Those are the people that actually execute the trials. Regulatory, patient safety, patient advocacy. Again, those cross-functional team members.
I mentioned some of the titles already. Some of the transferable skills would be clinical experience, clinical trial experience. But here it doesn't have to be that you were the PI on a phase three pharma-sponsored randomized double-blind placebo-controlled study. It can be that you participated in research and that can be retrospective as well. Data analysis, publications.
Without clinical research experience, I typically would say to people, clinical development will be the hardest place to enter. But if you have research experience, which many of you do, then there are opportunities to come in through clinical development.
Moving to pharmacovigilance, again, drug or patient safety. This involves all things safety data. Those physicians are really not thinking about the efficacy of the drug. They are focused on safety and they have to understand the whole safety package around the drug from when it was first put into cells and into animals all the way through.
They're focusing on understanding all the available data and trying to assign whether or not there's relatability to a side effect to the drug, but maybe it's related just to the disease that we're trying to treat. And that's where the clinical knowledge comes into the patient safety role.
They have significant interactions with clinical development, with regulatory. I think I had no idea coming into the industry how much safety data we have to send to agencies like the FDA every, not even just year, but there are reports that are required by law that go in and these safety physicians are highly involved in those.
Some of the titles, associate medical director, medical director. And transferable skills here, your clinical experience. You're the one that understands pharmacology. You're the one that understands the actual clinical disease and that understanding is what you bring to the table for a safety role.
Clinical trial experience is a plus, but not a necessity. And if you have any experience as a principal investigator, that's PI or sub investigator where you've had to report safety data, again, that's a plus as well, because you understand the reporting process, but that's something that you can learn in the job. It's really that clinical experience that comes as the transferable skill.
And then moving to medical affairs. I actually find medical affairs to be the more difficult of all three to explain to people, because if I talk to you about a clinical trial protocol, most people can get that safety, but medical affairs is a bit nebulous. The definition is the external scientific medical arm that takes clinical or medical information from the company to external stakeholders, such as those key opinion leaders and patient groups, even more importantly these days. They share that information and they bring information back into the company for us to integrate into our development.
Medical affairs is engaged in the scientific exchange of information with external stakeholders. Those stakeholders might be, as I've said, thought leaders, but healthcare providers generally. It doesn't have to be Professor Smith, who's the best neuromuscular doctor in the whole of the United States. Yes, Dr. Smith is probably important, but the doctors who are treating the neuromuscular patients day in and day out are also very important to me. And I'm using neuromuscular as an example, it could be endocrine, it could be cardiovascular. But getting that information, what do they need from drugs? What is an unmet need? What is not being met appropriately? And again, patients and patient family input as well.
They're sharing that scientific and clinical knowledge and they're gathering that scientific and clinical knowledge. They also are very engaged in teaching. Oftentimes, I'm asked to give a lecture to a group of laboratory colleagues who they understand what they're doing at the bench, but they might not understand the disease they're actually working on and helping them understand it and talking to them about what happens to the patient helps them really understand why they come to work every day. So there's a lot of teaching involved in med affairs.
And you're interacting with a lot of people, clinical, but here may be more commercial colleagues and also regulatory because we are a highly regulated industry and anything we take outside, we have to get approval to do so. Regulatory is an important part as well.
Similar titles, again, I'm going to leave medical science liaisons for tomorrow night, but associate medical director, medical director and transferable skills here, again, that clinical experience. And if you have experience with data analysis, with publications, that can be a really nice addition as well, but again, not absolutely necessary.
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