"Physician Roles in the Pharmaceutical Industry" by Sylvia Baron
Healthcare reform has had a dramatic impact on the traditional practice of medicine, and physicians are increasingly opting to diversify their career choices. However, because of a lack of suitable information, physicians are frequently unaware of the broad range of opportunities where they can utilize their skills and knowledge within the healthcare industry. The pharmaceutical industry provides one such opportunity.
The increasing regulatory environment in the drug approval process has made the role of the physician pivotal for the primary objective of this industry: to develop novel, safe and effective therapeutics. The drug approval process is very lengthy, costly, and highly regulated. Once it is determined that a drug in the preclinical stages is safe and viable for further testing in humans, the knowledge and expertise of the clinician becomes an essential tool in the further testing of this potential new drug candidate. In order for a drug to obtain regulatory approval, it must undergo various stages or phases of clinical testing.
Within these stages, physicians play a role in:
Clinical Pharmacology (Phase I)
Clinical Research (Phases II and III)
Medical Affairs or Clinical Development (Phases IIIb, IV, and V)
At each phase the focus of the clinical studies changes. Phase I includes first-time-in-man pharmacokinetic and pharmacodynamic studies where the safety and therapeutic dosage of the drug is established. Phase II involves intensive testing for efficacy. Phase III includes large, multi-center clinical studies with various subpopulations in order to demonstrate with a high degree of statistical significance the efficacy and safety of the drug. This phase is key to the submission of a new drug application for FDA approval.
In addition to these roles, physicians may also work in other areas such as:
Medical Services, where responsibilities focus on medical information, marketing, and promotional activities related to the company's various products.
Regulatory Affairs, where the physician becomes a key liaison between the company and the regulatory authorities through writing reports and participating in meetings.
Drug Surveillance or Drug Epidemiology, roles that are particularly suited for physicians with an interest and/or formal training in epidemiology. Responsibilities in these roles include the epidemiologic analyses of safety data in clinical and adverse experience databases, planning and conducting postmarketing surveillance, and other safety studies on the company's drugs.
Physicians well-suited for a career in pharma find themselves in an environment that offers them considerable intellectual challenge with great professional rewards. The opportunity to interact in a multidisciplinary team can be highly stimulating. Physicians work closely with statisticians, clinical research associates, marketing professionals, regulatory affairs experts, and many other members of the drug research and development team. Their new career provides them with variety in their daily work, with projects that include designing new studies, writing clinical protocols, selecting investigators, monitoring studies, preparing medical reports, and determining the statistical importance of findings of clinical trials. Finally, a career in pharma provides some physicians with a sense that they can have a broader impact on patient care than they would otherwise have in a traditional clinical practice. For these individuals, collaborating in the transfer of basic science advances to clinical care provides a sense that they are leveraging their intellectual contribution to a greater extent than they could in direct patient care.
Despite the many advantages of this career path, there are some potential drawbacks that physicians need to evaluate before making this choice, including:
Loss of clinical role and identity: In most cases, there is little opportunity for physicians in pharma to continue practicing clinical medicine. In some cases, physicians can negotiate perhaps one day per week of clinical practice as a part of their full-time employment contract with a pharmaceutical company, but it is rare to secure more practice time than this.
Loss of autonomy: Working in a pharmaceutical company means working as a member of teams. This is a substantial shift from the autonomous role of the traditional clinician/academician. This transition is more difficult for some physicians than for others.
Loss of "hands-on" role: For individuals who have a strong scientific orientation and are tied to bench research, the limited opportunity to continue this level of involvement can be difficult.
Willingness to travel: Many positions in the pharmaceutical industry require that individuals spend up to 30% of their time traveling.
Short term loss of earnings: Physicians making mid-career transitions into the pharmaceutical industry may need to accept a lower salary initially. The long term financial gains however, far outweigh any short term losses.
If possible, it is helpful to define one's interest in a career in pharma before a specific area of specialty training is selected. Physicians who can most easily make this transition are internists, pediatricians, neurologists and psychiatrists, dermatologists, ophthalmologists, and obstetrician/gynecologists. Anesthesiologists, pathologists, and most surgical specialists have fewer possibilities primarily because less research and development is underway in drugs relevant to these specialties.
It is not critical to pursue this professional move early in one's medical career. However, the longer the physician waits, the more difficult it becomes for the individual to enter the industry in a position that is commensurate with his/her level of professional experience. In general, most companies seek physicians who have, at the very least, about two years of clinical experience post-residency or post-fellowship training, up to about ten years.
While not essential, it is also recommended that the physician gain experience in basic and/or clinical research, maintain a publication record, and pursue additional training. Specific areas of advanced training that greatly enhance one's marketability in the pharmaceutical industry include: drug epidemiology, clinical outcomes, disease management, medical informatics and pharmacoeconomics.
And finally, it is very important that the physician be a good communicator. Physicians in the pharmaceutical industry tend to have very high visibility roles which demand strong oral and written communication skills.
The pharmaceutical industry provides an exciting and increasingly popular alternative career pathway for physicians. Physicians seeking a career that allows them to utilize all aspects of their scientific education, medical training, and clinical/academic experience may find just that in the world of pharmaceuticals.