Physicians, the Pharmaceutical Industry, and Consultants
Updated: Dec 3, 2021
How does a physician transition to working in the pharmaceutical industry or from industry to independent consulting?
Years ago, while working in clinical research, I received a call from a former colleague. A couple of years earlier, I had suggested to him that he might be happier working in the pharmaceutical industry rather than battling for resources. He did take my advice.
Another colleague of ours had left his academic position. On a visit to our institution, his transformation was dramatic. He no longer looked exhausted, frustrated, annoyed, and agitated. He was relaxed, had lost his excess weight, and looked happy. In fact, he smiled, as he recounted the joys of industry. Once he made a good case for clinical development of a drug and the plan was approved by his company, the necessary money to conduct the trial was available. By academic standards, the amounts of money were staggering.
Yes, he was very happy! He was the most recent and prime example of a successful transition to industry. But there were others, too.
Why did my former colleague call? It was to ask if I might be interested in a job in industry. I had thought about it a great deal, and had received many calls and emails from head hunters. This was different. It was local. It would be working with some people I knew. Still, I needed some time.
I called him back. Yes, I was interested in pursuing it. A head hunter would interview me.
Soon, I was working at a fairly large pharmaceutical company in the area of clinical development. It fit very well with the aggregate of my interests and experience.
It was exciting! The projects were fascinating and the teams that worked on the projects were amazingly driven and efficient. The teams had representatives from manufacturing, research, regulatory, clinical operations, medical, project management, drug safety, and other departments.
Collaborations with the research group were amazing. I had worked in the laboratory in my career, but this was a different level. Teams of researchers would present masses of data every week. The sheer pace of research was staggering.
Then there was the parade of the world's leading experts to pressure test all of our assumptions and plans. The process was extremely rigorous and it was a great learning experience, too.
Often, studies are criticized because the experts are frequently on many clinical trials in a field and are paid for their services. The view that they are biased by their financial interest did not seem to hold water. It seemed to me, then, as we sought advice on development of products that we would want the best people possible. Since everyone wanted the best advisors, they would be the greatest experts and would be on the most studies and advisory boards. These key opinion leaders were also advising our competitors. They certainly did not give us an easy pass on anything.
Everything was pressure tested up and down the organization. The company wanted everything to be performed to the highest standards, following the regulations to the letter, and a great emphasis was put on ethics. It was imperative to avoid anything that would fall afoul of the regulations or end up with bad press.
A stark difference between academia, which tends to be focused on grants and knowing more and more about less and less, and industry was the focus on bringing drugs to market or licensing them out.
Ultimately, it is the sale of products that pays for development on new ones. Because of this, you could work for several years with the world's experts, and become highly expert yourself in an area. Then you would reach a critical go no-go decision point. If it was a no-go, e.g., a clinical trial failed to meet its endpoints, you were done. Next!
As soon as possible, you would move on to your next priority. It might be in an area where you have little expertise, and the learning would begin. In academia, you might focus on an interesting observation in the trial and continue working in your area of expertise.
Who does the pharmaceutical industry seek as consultants?
If you are a world expert and your institution allows it, you are likely to be consulted by industry. As long as you remain an expert in a relevant area, your opinion may be sought.
Industry engages with a host of experts in any of the aspects required in the drug development process, assessment of potential markets, etc. This includes regulatory experts, such as those who have previously worked at the US Food and Drug Administration.
What if you are a world expert in an area of medicine or medical research and you want to work in the pharmaceutical industry?
You may enter the industry in a high level position and be paid extremely well. You would probably have far more resources than you would in academia.
What if you are a physician, who is not a world expert, and you want to work in pharma?
A number of jobs might be available (which could also be available to world experts).
You could enter as a physician in:
Some of this work may be about how to position a drug in development, when presenting information to physicians. For drugs that are on the market, you would become an expert on the indications, safety, and efficacy of the drug and its pros and cons compared with competitors. There is of course much more to this.
If you have regularly presented at rounds and are considered to be knowledgeable, or if you known locally as a go to physician, this could be a good fit.
This is also known as product safety or as pharmacovigilance.
It involves evaluating the risk profile of the drug, ensuring that serious adverse events are adequately evaluated and that they are reported in a timely manner to regulatory authorities.
In the United States, working in this area does not require having a US medical license. The physician overseeing safety must have a medical license, even if it is not in the US. Somewhere in the chain of oversight at a company, though, there is generally a US licensed physician. Nurses and pharmacists also often work in pharmacovigilance.
This is where the overall plans for developing a drug are devised and implemented. The work includes consideration of what research studies might be necessary to support first in human studies, what the initial safe dose might be for dose escalation studies, the design of clinical trials along the development pathway, the go no-go decision points, the potential safety issues, and possible indications. The plans can take into account everything from pre-clinical to post-marketing considerations, especially in big pharma companies. Startups tend to focus on getting to Phase 2a, licensing the treatment out,
and moving on.
A background in clinical research and clinical trials is an advantage when entering clinical development.
A phase 1 unit
This is if the company has their own unit. You would evaluate and manage patients and healthy volunteers as you might in working as a physician in a clinic or research unit.
I have personally and unexpectedly found this to be very enjoyable. Companies may need your medical, clinical, and research support as they present programs to investors, to potential partners, or to evaluate opportunities for potential acquisitions or mergers with other entities. This involved a great deal of travel in my case and has only been a part of my work. It is extremely interesting to see how other companies approach clinical development or research initiatives.
Other areas for physicians
This is not meant to be an exhaustive description of all of the kinds of physicians that might work in the pharmaceutical industry, but here are a couple of examples. Pathologists may work on pre-clinical and clinical studies. In big pharma, radiologists may have a role.
What if you are a physician who works in industry and want to make the transition into independent consulting?
This is an option, and this is what I did.
Startup companies often need general clinical development and drug safety expertise. If you have substantial industry experience in this area, it would valuable to your prospective clients.
Large and established companies tend to be more interested in a specific niche, since they have well developed systems and programs. Before going into consulting, you should consider what your niche is, and why such companies might want your services.
Before making the transition to consulting, it is wise to set up a business structure to enhance your legal protection, and to separate your personal from your business finances.
If possible, it is good to work for your current employer, when you make the transition. People you have worked with are often a great source of referrals.
For the steps to setting up your business, see the page on this website: Get started.
Please let me know your thoughts and leave your comments.