Think you might be interested in a career in pharma, but not quite sure how doctors work for pharmaceutical companies? Listen to this episode to learn about physician roles in clinical research and contract research organizations (CROs), and see if that might be a potential career path for you!
In this episode of The Career Rx we’ll discuss:
- Physician pharma jobs with contract research organizations (CROs)
- What doctors do in pharmaceutical research and development
- How to start a career in pharmaceutical clinical development – including basic qualifications
- Remote nonclinical physician careers – this can be one!
Today’s episode is a continuation of a series that’s specific to the pharmaceutical, biotech, and medical device industry. In this overview of careers in clinical research and CROs, I give a high level idea of what they are all about, some of the top names to get your career search started, and what type of roles are available for physicians. And, yes, for many companies, these are remote nonclinical jobs for doctors!
In this Episode:
[1:45] You don’t have to get a job with a top pharmaceutical company to work in R&D
[3:30] What’s a CRO, and what are some well-known CROs to check out?
[6:45] Physician responsibilities and pharma company/CRO duties
[7:26] Protocol development, working with trial sites, and medical monitoring
[8:25] An easy resume boost to learn this world AND boost your marketability
Ready to learn more about exactly how to find those kinds of jobs, or how to critically evaluate your own skills and experience for transferability? Join my course Industry Insider to get you the results you want, faster.
Links and Resources:
Industry Insider – learn exactly how to land a rewarding nonclinical career without a new degree, connections on the inside, prior experience, or a pay cut
The Branding Rx – 18 hours of CME, mastering digital strategies for advancing your career, building your business, and growing your professional brand
Episode 88 – What Physicians Do in Pharma: Drug Discovery and Development
Episode 89 – Physician Jobs in Pharma: Medical Affairs
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Thanks for joining me on this episode of The Career Rx!
TRANSCRIPT: Episode 90 – Physician Jobs in Pharma: Clinical Research and CROs
Hey there, I’m Marjorie Stiegler and you’re listening to The Career RX podcast, where we tackle the important things they don’t teach you in medical school. Like how to treat your career, like the business, it really is, with strategies to accelerate the kind of success that you want, because you deserve a career you love, and a career that loves you back. Are you ready? Let’s get into it.
Hey there, welcome back. We are doing a little mini series on the podcast of pharma related physician jobs. One of the things I’m often asked about is, you know, what, what exactly do physicians do within the pharmaceutical industry? And the answer to that is there are so many things.
So I’m covering those in this sort of mini series within the podcast, talking about medical affairs, pharmacovigilance, clinical development, and today I’m going to touch briefly on contract research organizations or “CROs.” I always want to call them clinical research organizations, but they’re contract research organizations and they are really exactly what they sound like. They are contractors, and they work together with pharmaceutical companies or, really, for pharmaceutical companies to conduct portions of the research.
So for physicians who are interested in working in either in the pharmaceutical industry, a contract research organization is certainly within the industry. For physicians who are interested in working directly for pharmaceutical companies.
Working for a CRO is a really great way to develop some extremely relevant and highly transferable skills. contract research organizations can really offer a really broad number of services to the pharmaceutical companies including preclinical research, those phases of clinical research and clinical trials that we’ve talked about clinical trial management and even pharmacovigilance.
So, in some ways, a lot of the different functions that the pharmaceutical companies have are, are done or could be done by a CRO. CROs exist to help reduce costs for companies developing new medicines. And I guess particularly for smaller companies who wouldn’t have all of that, you know, “in house” or for rare diseases or medicines being developed in very niche markets. So the outsourcing of those studies, the trials and some of the pharmacovigilance is, is an economical decision.
CROs can also work directly with research institutions, sometimes with academic organizations, universities, or even governmental organizations like the NIH. Now, I don’t personally have experience working within a CRO so I’m, again, just as with many of these things, I’m giving you that high level idea of what CROs are all about and what one might go do there.
But in general, I mean, CROs are essentially providing clinical study support and clinical trials support for medicines, or medical devices, as they’re moving from that conception through the approval phase. And generally speaking, the purpose for that is so that the company that is the sponsor, right, the company that has developed the medicine does not have to maintain their own internal staff for all of that.
One of the really important things to know about a good you know, high quality CRO is obviously, the CRO has to have quality assurance, they’ve got to have really strict quality controls, because if the studies are being outsourced to the CRO, the CRO has got to, to orchestrate that in a way that is reliable, right? That that’s a very high quality so that the results are, you know, have full integrity and that they meet all the requirements that the sponsor has and the regulatory agencies have.
And it’s probably also important to know that even though a sponsor or a pharmaceutical company can hire a CRO are contracted with a CRO to conduct these, the ultimate responsibility that accountability for the quality integrity of the trial data always resides within the pharmaceutical company itself. So it’s not like you can outsource and shift responsibility on to the CRO, the CRO is that partner who’s really involved in a lot of the logistical execution. But the pharmaceutical company is absolutely still responsible for the quality and the integrity of all of the clinical trials and all of the trial related data.
If you’ve never heard of a CRO before, and you want to kind of poke around and you know, get to know some of them. Some of the most notable ones, the largest ones, I guess, are the ones that I’m aware of – one is Syneos Health, another one is Parexel, you could look at ICON, you could look at pharmaceutical product development, also called PPD.
I have no relationship to any of these companies, they’re just ones that I hear very frequently, so, you know, they’re, they’re ones I’m aware of, that could help you just kind of as you’re starting to look around and see what kind of companies are out there, what kind of work they do, how they describe their work, and what kind of positions they may have.
As I’ve mentioned, there’s a variety of functions that can be outsourced to a contract research organization. But one of the most common ones is that of the what’s called the medical monitor, this is usually a physician who is really deeply connected to the research and making sure that the research is done well as we’ve been talking about data integrity.
So the medical monitor is generally responsible for ensuring that all of the different clinical sites understand the clinical trial protocol. And they check in with those sites, they make some on site visits, they review the case report forms, they communicate with the clinical research coordinators on that site. They ensure that they ensure the protection and safety and well being of study subjects, they have to make sure that there’s scientific integrity of the data that is collected, protected, verified, and they have to ensure that adverse events are correctly documented and reported.
So the medical monitor or the clinical research physician, or sometimes it’s called a study accountable physician, this person is not conducting the research themselves, they’re really overseeing. But with a hands on approach, you know, all of these different sites and for many pharmaceutical companies, there are a lot of sites involved, because you of course, you want to have a very diverse group of enrollees of subjects enrolled.
And sometimes that will be all across the United States. Sometimes it will be in many countries around the world, there could be dozens or even hundreds of sites. And so it’s really important to be sure the people on those sites are doing everything the same way. Right with that integrity, and with that compliance with the clinical trial protocol. And these protocols can be very, very lengthy.
So if you’ve never been involved in a clinical trial, for drug development, you might be surprised the protocols can be extraordinarily long documents, and they can be really, really detailed. And especially at the beginning of a trial, clinical sites often have questions and questions will come up sort of as you begin to enroll subjects, there will be new questions that come up. And these things are generally managed by the medical monitor. And that person, or that person could work directly for the pharmaceutical company. But very often, that’s a function of the CRO.
One of the key things the folks who are working for the CROs are accountable to do, is to comply with all the regulatory agency guidelines, it’s really important, and to adhere to the standards that are called Good Clinical Practice. So while that just sounds like yeah, like day to day terminology, Good Clinical Practice is a specific and official set of standards. And you can get trained on Good Clinical Practice in a variety of websites, including the FDA website, for free, I believe.
So some of these, some websites will charge you to take, take a little course on good clinical practice. But I know there are free ones, I believe there’s free one on the FDA website. So if you’re interested in the clinical trial side of either a pharmaceutical company or a CRO and you’re thinking about transitioning, a really great idea is to go out and get really familiar with, or possibly even trained in good clinical practice standards, because that is a core part of the CROs role. And therefore if you are employed by the CRO, really an important part of your job.
And why would a company hire a CRO or contract with the CRO? I mean, one of the biggest and obvious advantages is that because CROs do clinical trials, like over and over and over and over again, for variety of sponsors with all different kinds of medicines, all different kinds of endpoints, all different kinds of locations and study sites and they really have it down to a science if you’ll forgive the pun.
I mean, they really do know how to execute on clinical trials in an efficient way. And they’re often able to anticipate the types of pitfalls or delays or problems that can occur with clinical trials. And so avoiding having to sort of reinvent the wheel is one of the main reasons that a sponsor might use a CRO in addition to not having that staff internally.
So again, that’s a very high level overview of CRO and their are opportunities for physicians both as medical monitors and in pharmacovigilance and perhaps other roles within CROs which is absolutely part of the pharmaceutical industry, though not specifically for a pharmaceutical company. So if you’re interested in that kind of work, that’s a really great place to begin your career, or certainly should be on your list as you’re exploring different companies. Don’t forget about the CROs.
Obviously, doing really, really well conducted clinical trials is of the utmost importance in ensuring that the right data come from those trials that can really inform whether the medicine is efficacious and safe, and if so how it should be used in clinical practice. So that’s really the backbone, I mean, a medicine doesn’t get approved and doesn’t get used without this kind of data being done really, really well.
So, to me, this is another really excellent way to make a major difference for patients on a macro scale in the pharmaceutical industry.
I hope this has been helpful to you as you think about the different ways in which you might look for physician jobs in the pharmaceutical industry. Please do check out the rest of the episodes in this series. To understand a little bit more about what doctors do in the pharmaceutical, biotech and medical device industries. It’s really great stuff.
And again, if you’re interested in really learning more about how to make that transition for yourself, please do come check out Industry Insider. This does not need to be mysterious. It is absolutely something you can do. And I can help. That’s all for today. Bye for now.