Making the transition from clinical practice to a career in the pharmaceutical, biotechnology, and medical device industry
What are motivations for physicians to seek a pharmaceutical industry career?
For an increasing number of physicians, a lifetime dedicated to clinical practice is no longer necessarily the norm. Many are considering and making the move to alternative careers as a complete transition or a part-time foray into new and uncharted waters. The pharmaceutical and biotechnology industries have naturally been regarded as fertile territory for the initiation and nurturing of such a new career path.
For some, the attraction is the promise of contributing to the health and wellbeing of large sectors of the global population through involvement in the discovery, development, licensure, and provision of access to novel therapies or interventions that may have a much further-reaching impact than the daily grind and revolving door of clinical practice. For others, increasing demands of clinical practice, and in many cases the attendant diminution in quality of life, coupled with an increasingly complex reimbursement environment and litigious landscape, may have conspired to instigate a search for greener pastures. Yet for an even more select few, an earnest passion for the pursuit of seminal translational scientific research is the compelling reason. I would argue that the driving force for a physician’s desire to take this leap is perhaps the most predictive factor for eventual satisfaction, or lack thereof, with a career in “industry” and often a predictor of future success or failure.
A range of opportunities are available for physicians in the pharmaceutical industry.
For a practicing physician, or indeed one who has completed medical school with or without residency training, opportunities exist at various levels of development and commercialization. Opportunities exist in discovery, preclinical and early stage, later stage clinical development, and licensure and marketing at manufacturers of vaccines, small molecule drugs, biologic therapies (such as monoclonal antibodies), medical devices, and even novel diagnostic tests. Opportunities also exist in functional areas ancillary but just as critical to the clinical development continuum, including regulatory affairs, drug and device safety, medical affairs, commercialization/market access, and health economics/outcomes research (HEOR). Physicians with formal graduate training in public health (MPH) and business (MBA) are often particularly suited to roles within industry, although neither of these qualifications is a pre-requisite for entry.
Here are a brief description of some of the functional areas within industry that represent potential career paths for transitioning physicians. Reference is made predominantly to pharmaceutical drugs and medical devices, however the underlying principles are generally applicable across all types of products within the pharmaceutical and biotechnology sectors.
Discovery – This is the process by which new candidate vaccines, medications, or devices are discovered. Physicians with prior training and experience in basic science disciplines pertinent to discovery, including molecular biology and medicinal chemistry, are particularly suited to a career in discovery.
Here are examples of opportunities in drug discovery.
Pre-Clinical Drug Development (Also known as Non-Clinical Drug Development) is a stage of research that is conducted before testing in humans and during which animal studies, and other experimental work, are done to determine preliminary safety and feasibility for advancement to human studies. This includes Pharmacokinetic (PK), Pharmacodynamic (PD), and toxicology testing. The latter in turn includes testing for potential carcinogenic effects (genotoxicity) of the candidate drug and potential deleterious effects on mammalian reproduction (reproductive toxicology). Few physicians are generally involved in PK, PD, or toxicology as a primary career, as these disciplines are the remit of basic scientists and clinical pharmacologists.
Here are job openings in pre-clinical drug development.
Clinical Development (Phases I, II, and III, i.e. Early Stage and Late Stage Clinical Development) involves clinical trials conducted with progressively larger numbers of subjects during which safety and efficacy of the drug, vaccine or device is tested in humans. These studies collectively, along with pre-clinical studies, are designed to generate a portfolio of data that regulatory authorities, such as the United States Food and Drug Administration (FDA), will use as a basis for approval and licensure of the product. The vast majority of physicians working in industry are involved in some capacity in early and/or late stage clinical development.
Here are clinical research job opportunities.
Medical Affairs (including Phase IV clinical development – the post-registration or post-licensure period) represents the post-licensure period when strategic activities to ensure appropriate use, as well as prescriber and patient awareness of the product, are conducted. Issues pertaining to emerging safety signals in subjects who receive the now-licensed product are also attended to, with appropriate liaison with regulatory authorities such as the FDA and European Medicines Agency (EMA). Medical Affairs physicians also work in close collaboration with company commercial colleagues and legal counsel in matters pertaining to product promotional activities, and patient access to the product.
Here are examples of medical affairs jobs.
Regulatory Affairs - Regulatory Affairs professionals are responsible for keeping abreast of legislation in all geographic regions in which the company distributes its products and are responsible for the submission of registration documents to regulatory agencies, as well as negotiations for marketing authorization for the company’s products. Their roles and responsibilities span all research and development activities, including preclinical development, all phases of clinical development, premarket approvals, manufacturing, labeling, promotional activities, and surveillance for post-marketing product-associated adverse events. Relatively few physicians begin their pharmaceutical careers in regulatory affairs, although there are a few, usually larger, pharmaceutical companies that have a predominance of physicians in this role in certain therapeutic areas. Time spent in a role in regulatory affairs is considered a good way of gaining valuable experience in tackling critical challenges that can make or break a clinical development program, regardless of the ultimate career goal of a physician within industry.
Here are job openings in regulatory affairs jobs.
Pharmacovigilance and Drug (or Device) Safety - Pharmacovigilance involves the detection, evaluation, and prevention of adverse events that are temporally and/or causally related to the drug or device. It begins in the clinical stage and continues throughout the product life cycle in pre-marketing and post-marketing stages. Physicians typically work alongside safety scientists, usually as the designated safety physician for a group of products within or across a range of therapeutic areas, This is a relatively common role for physicians in industry.
Here are examples of pharmacovigilance jobs.
Health Economics and Outcomes Research or Pharmacoeconomics - Health economics is a branch of economics concerned with the cost-effectiveness of various health care interventions, including drugs and devices. Outcomes research seeks to understand the results of such interventions, especially those that have a measurable and meaningful impact on the wellbeing of patients, and the cost of treatments for their illnesses in real-world situations. By linking the care people get to the outcomes they experience, outcomes research has become the key to developing better ways to monitor and improve the quality of care. Physicians in industry often play an important role as part of HEOR teams, providing perspectives based on their clinical practice background, and exposure to health care payer environments. This is an attractive field for physicians seeking a career in industry, with an increasing number of physicians now undertaking formal training in health economics and outcomes research.
Here are available jobs in pharmacoeconomics (Outcomes Research).
Commercialization/Marketing – including Market Access – A relatively small but significant number of physicians take on roles within commercialization/marketing teams in pharmaceutical companies. These are very often physicians with some formal graduate training in marketing or related fields, usually an MBA degree. Their role involves advertising, and other promotional activities for the company’s drugs or devices, to consumers and key stakeholders, including patients, prescribers, and payers. Physicians that take on a role in commercialization are perhaps the most prone to issues of conflict of interest should they desire to continue to have some degree of involvement in clinical practice.
A wide range of opportunities exists for physician seeking a career in the pharmaceutical industry. These span the continuum of drug development as well as post-licensure activities: from the discovery of novel drugs and devices, through clinical trials to demonstrate safety and efficacy, to the monitoring of the safety and effectiveness of licensed products and their role in the provision of cost-effective treatments in real world situations. The key to a physician’s successful transition into industry is an understanding of one’s motivation for taking the initial step. A career in industry and one in clinical practice are not necessarily mutually exclusive, with many physicians maintaining part-time involvement in clinical practice. In such instances, it is important to be aware of the potential for conflicts of interest, and how to avoid these.
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