Physicians, the Pharmaceutical Industry, and Consultants

Here are some pointers for physicians would want to be consultants in the pharmaceutical industry. Depending on your backgrounds options abound!

The call

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 to take up a job with a pharmaceutical company. 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.

Here’s what he loved about his new job. After battling year after year in academia to do small trials with meager resources, his situation in industry was a total game changer. Once he made a good case for clinical development of a drug, the company would approve the plan, and they would allocate the necessary money to conduct the trial. By academic standards, the amounts of money were staggering, and he had the resources he needed to do appropriately sized clinical trials.

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 consider 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 to think about it.

I called him back. Yes, I was interested in pursuing it. A recruiter would interview me.

The transition

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 their financial interest overly biases them 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.

The work was rigorous and ethical

Everything was pressure tested up and down the organization. The company wanted everyone to perform their work according to the highest standards, to follow 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.

The emphasis was different from that of academia

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.

What physicians do the pharmaceutical industry seek as consultants?

If you are a world expert and your institution allows it, industry is likely to consult you. As long as you remain an expert in a relevant area, your companies may seek your opinion.

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.

Are you a world expert in medicine or medical research who wants to work in the pharmaceutical industry?

You could enter industry in a high level position and for extremely good pay. You would probably have far more resources than you would in academia.

If you have not been approached by industry, you could work with recruiters.

If you are one of those physicians who is already among those who are pharmaceutical industry consultants, your clients may not know that you are interested in making the transition.

What about physicians, who are not world experts, and 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:

Medical affairs

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.

Drug safety

Other names for this are product safety or pharmacovigilance.

It involves evaluating the risk profile of the drug, to ensure adequate evaluation and reporting of serious adverse events to regulatory authorities in a timely manner.

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. Though, a US licensed physician is generally somewhere in the chain of oversight at a company. Nurses and pharmacists also often work in pharmacovigilance.

Clinical development

This is the department that devise and implements the overall plans for developing a drug.

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.

Business development

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

What has already been covered is not meant to be an exhaustive description of all of the kinds of work physicians that might do in the pharmaceutical industry, but here are a couple of additional examples.

• Pathologists may work on pre-clinical and clinical studies.
• Radiologists may have a role in big pharma.

If you are moving into the pharmaceutical industry, it is helpful to prepare by attending courses on clinical development, drug safety and regulatory aspects, such as those mentioned the blog article, How to move to independent consulting in clinical operations. While the work of those in clinical operations and physicians in industry are different, the content knowledge overlaps.

Physicians working in the pharmaceutical industry can develop invaluable knowledge, skills, and experience that can prepare them to become consultants.

Are you a physician who works in industry and wants 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 consulting business, see the page on this website: Get Started.

Not sure yet, if you want to be an independent consulting?

See, the About page about my own experiences in planning and making the transition.

Not sure yet, if you want to go into consulting? See my posts on:

1. Who can be a consultant?
2. So, you want to be a consultant?
3. Learning about consulting
4. Making the transition to consulting in the pharmaceutical industry

Please let me know your thoughts and leave your comments.