Pharmaceutical and biotech companies hire physicians (MDs and DOs) for a variety of different positions. Physicians who have a passion for drug development can make a broad impact on patients and healthcare when they transition to industry from patient care or academic research.
Opportunities exist for both newly qualified physicians as well as highly experienced physicians who are leading experts in their sub-specialties. The former typically enter the pharma industry as project physicians or study-responsible physicians. The latter join as medical experts or in executive leadership positions.
Learn how to get a pharma job in our interview with a recruiter who specializes in physicians entering pharma.
Pharma companies usually comprise several entities, like Research and Development (R&D), Commercial, and Manufacturing. These entities are typically organized into different functions or departments. Many of these functions, particularly the R&D and Commercial organizations, have positions suitable for physicians or those with clinical or biomedical training and experience. Of course, job titles and job descriptions vary across companies. The following are generally the functions and types of positions that physicians hold.
Physicians in Pharma R&D
Preclinical and translational research
Physicians who work in preclinical or translational research investigate and identify drugs (often called “new molecules” or “molecular entities”) and drug targets. Physicians in translational or biomarker research help select or conduct the assays that are most appropriate for clinical samples. They may also work in diagnostic assay research.
Preclinical and translational researchers examine novel uses of existing drugs. They also evaluate drugs for safety and tolerability in animal models. In addition, they help validate and interpret pharmacodynamic or pharmacokinetic data from clinical trials. These researchers often have experience in medicinal chemistry and pharmacology. Their responsibilities include developing and implementing experimental strategies as well as authoring or reviewing regulatory documents.
What are regulatory documents? Regulatory documents typically refer to submissions, filings, applications, and dossiers related to regulatory approvals. Examples include the IND (Investigational New Drug) and NDA (New Drug Application), as well as other reports and amendments.
Pathology
Pathologists and molecular pathologists often work directly with the preclinical and translational research teams on projects like new drug target identification. For example, they bring their techniques and expertise in immuno-histochemistry to demonstrate the expression of a particular drug target.
Biomarkers
In the current era of Precision Medicine, physicians may also have roles such as Biomarker Lead. They are responsible for developing a plan to collect samples from patients enrolled in clinical trials. Then, they coordinate the assessment and analysis of those samples to demonstrate the pharmacodynamics of the experimental drugs. Biomarker Leads may also develop and execute assays to understand which patients respond to the drug. They also investigate mechanisms of drug resistance.
Diagnostics
Diagnostic Leads develop diagnostic assays. Diagnostic assays are used to select the patients expected to respond to a particular therapeutic. For example, PD-L1 staining using a diagnostic assay determines patient enrollment eligibility in trials for anti-PD-1 drugs. Diagnostic Leads also develop and implement the strategy for getting regulatory authority approval for the diagnostic assay as a companion diagnostic alongside new drugs.
What is a drug target? It is a molecule in the body, typically a protein, associated with a disease process. It can be addressed by a drug to produce a desired therapeutic effect.
Toxicology
Physicians also work within Toxicology departments to ensure that drug targets are specific. For example, they may investigate whether non-cancerous tissue expresses a cancer drug target. In cases where the drug targets may not be specific, they evaluate the risks of the drug treatment. In addition, they perform the necessary experiments prior to first-in-human trials. Physicians in this role may be responsible for writing important sections describing these experiments and risks in regulatory documents.
Early- and Late-Stage Clinical Development
Physicians with experience practicing medicine and conducting clinical research in academic or community healthcare settings bring valuable experience to pharma. Indeed, they use that expertise to help formulate and execute the clinical development strategy for a drug. This includes designing clinical trials, writing clinical trial protocols, preparing clinical trial documents, and assessing the risk-benefit of products. Often, physicians in these roles work closely with clinical scientists to help them achieve these goals.
What is the difference between preclinical and clinical development? Preclinical, or non-clinical, refers to the research and tests that are conducted prior to human testing. This work assessed the features of the drug, typically in vitro or in animal models. Clinical development begins when testing a drug for efficacy and safety in humans. Clinical trials are conducted to treat, prevent, or relieve the symptoms of a disease.
Early-stage clinical development
Physicians in early-phase clinical development may lead the first-in-human Phase 1 trials. They also investigate the appropriate dose of the new drug. Further investigation of the drug in Phase 2 trials helps to determine the efficacy and safety in larger groups of trial participants. Physicians working on these trials examine the data and experiences of both treating clinicians and patients from these trials. Then, they recommend to senior management whether and how investigations of the new drug should continue.
Late-stage clinical development
In late-stage clinical development, physicians lead the proof-of-concept or confirmatory Phase 3 trials. Physicians in clinical research interact with many internal pharma colleagues in their work to run the clinical trials. These may include biostatisticians, clinical research associates, clinical pharmacologists, and database managers, just to name a few. Plus, they collaborate with external investigators located around the country or around the world. These external experts enroll the clinical trial patients and serve on advisory boards. In addition, pharma physicians may also interact with regulatory agencies to discuss and gain agreement on proposed clinical trial designs or clinical development strategies.
The positions held by physicians in early and late-stage clinical development may range in responsibilities and scope. For example, Study-Responsible Physicians or Clinical Leads design and lead individual trials. In the meantime, Medical Directors may be responsible for the overall strategy for a particular investigational drug. Depending on the size of the portfolio and pipeline in a company, physicians may hold leadership positions that oversee the development of multiple products or entire therapeutic areas (like oncology, ophthalmology, etc.).
Check out our highlight of the Clinical Science function to learn more about working in clinical development.
Physicians in Pharma Medical Affairs
Medical Affairs is the external facing department within pharma companies. This function is responsible for communicating scientific information and data from the company to key opinion leaders (KOLs) and vice versa. The Medical Affairs department is responsible for a variety of activities and deliverables. These include publications, participation in scientific congresses, advisory boards, investigator-initiated studies, reviewing medical information response letters, and serving as the medical expert on internal cross-disciplinary panels.
KOL, KEE, TAE - what are all these acronyms? Companies will use different acronyms to describe the leading specialists in the medical world. They are called “key opinion leader” (KOL), “key external expert” (KEE), and “therapeutic area expert” (TAE). There may be other terms too!
Physicians hold many positions in Medical Affairs, though nurses, PhDs, and pharmacists often find suitable positions as well. Medical Affairs is usually organized to include global teams, which set the overall strategy for a therapeutic or disease area. These teams are then supplemented by country- or region-specific teams, which are responsible for local strategies and tactics.
Medical Science Liaisons
Medical Science Liaisons (MSLs) interact with KOLs as field representatives. Pharma companies hire MSLs to engage with practicing physicians and researchers about the company’s drugs. Such scientific conversations may include sharing new results from publications and exploring opportunities for scientific collaboration. Oftentimes, academic investigators will work with MSLs to inquire about the availability of drugs for research purposes. Given their relationships in the field, MSLs may also partner with the internal clinical development teams to identify appropriate investigators to participate in the company’s clinical trials. This position is usually remote and involves a lot of travel (in non-pandemic times) to visit hospitals, clinics, and universities, as well as to attend medical conferences and trainings.
Check out our highlight of Medical Science Liaisons.
Medical Directors
Within pharma company Medical Affairs departments, Medical Directors help set the medical affairs strategy for a particular drug or set of drugs in a therapeutic or disease area. Physicians who hold these roles will plan and lead advisory boards to engage with experts in the specialty area. They also coordinate field engagements with MSLs, including the attendance and presentations at scientific and medical conferences. Medical Directors often provide the scientific review of regulatory documents and promotional materials. A large part of a Medical Director's time may involve providing medical and safety oversight of investigator-initiated studies.
What are Investigator-initiated studies (IIS) or Investigator-initiated research (IIR)? These are trials or studies of the company’s drugs that are initiated by external investigators, such as those at major academic centers. These studies may assess the drug’s effect in unique patient populations or investigate hypothesized mechanisms of actions. IIS and IIR are usually complementary to the company’s drug development plan.
Physicians in Medical Affairs hold positions of varying responsibility depending on their levels of seniority and experience. Titles might range, for example, from Medical Director to Global Medical Affairs Lead. Senior leaders in Medical Affairs set the overall Medical Affairs strategy for a particular drug or multiple drugs in a therapeutic or disease area. They may also participate in cross-functional teams, such as those that set the clinical development or commercial strategy. Medical Affairs physicians offer the Medical Affairs perspective and communicate insights gained from engagements in the field. In addition, they also ensure that the strategies from all departments are aligned and can be executed on the country or regional level.
Positions in Drug Safety and Pharmacovigilance
Physicians and other pharma professionals with clinical expertise and patient care experience, such as nurses and pharmacists, play a very important role in pharmacovigilance. Their overarching goal is to improve the safe and adequate use of medications and to ensure patient safety.
Safety Scientists or Pharmacovigilance Specialists collect and monitor the adverse events from clinical trials and routine clinical practice. Physicians working in Drug Safety will collaborate with those in clinical development to manage the adverse events observed in trials. Adverse event reporting and assessment may lead to other actions being taken, such as dose adjustments and treatment discontinuations. Pharmacovigilance physicians interpret adverse event data and generate safety reports. When warranted, Safety Scientists discuss safety signals with health authorities and communicate with clinical trial investigators or other healthcare providers. Physicians in this function also determine the drug safety information that must be included in the drug label.
Check out our highlight of the Safety Science function and a Safety Science physician.
Upon the conditional or full approval of a new drug, health authorities may require additional studies to be conducted. Oftentimes, these studies aim to better understand the safety of the drug. These studies may need to be conducted in patient populations that were not included in the original clinical trials. Physicians working in Drug Safety will be responsible for designing and leading those post-authorization or post-approval safety studies. Based on new data collected on marketed products, pharmacovigilance specialists may recommend label changes, such as additional warnings and precautions.
Roles in Regulatory Science
Physicians who are interested in the pharma company’s interactions with regulatory agencies may find a role in regulatory science (or “regulatory medicine”) to be a good fit. Some of these physicians may have prior work experience within regulatory authorities, such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Importantly, Regulatory Scientists coordinate the writing and submission of documents to regulatory agencies. These are documents that are necessary to obtain or maintain the marketing authorization for a drug. They include the NDA, marketing authorization applications (MAA), drug labels, among other applications or supporting documents.
Within pharma companies, the Regulatory Science department implements regulations and provides strategic support for other departments. In particular, they implement policies regarding compliance with good clinical practice (GCP) and good pharmacovigilance practice (GPP).
Other Physician Roles
In addition to the roles described above, physicians in pharma and biotech companies may take on roles based on additional training or skill sets. For example, physicians who have experience with data analytics may be hired as Data Scientists. Those with training in health economics or business may gravitate towards positions in market access or other commercial functions. Moreover, larger companies such as Janssen and Merck have departments dedicated to global public health efforts, such as vaccine implementation. Thus, physicians with public health training or interests may find suitable roles in those departments.
Senior leaders in pharma and biotech companies often have medical training in their backgrounds. Many of them join industry in one of the roles described in this post, quickly acquire knowledge and skills in the business, and gradually take on leadership roles. Some physicians who are the leading external experts in their sub-specialties, often with decades of research accomplishments and leadership success, are sometimes plucked from academia to lead research efforts in pharma. The roles might be in senior and executive management or c-suite level (such as chief medical officer, CMO).
How Do Physicians Get Positions in Pharma?
The skills and experiences required for positions in pharma vary based on the type of positions described above. For example, positions in biomarker and diagnostics research typically research experience analyzing or developing biomarkers and diagnostics for clinical specimens. Physicians interested in safety science or early/late clinical development usually have experience as principal investigators (PIs) or sub-PIs on clinical trials. That experience includes familiarity with clinical trial documents and documentation processes. Oftentimes, physicians in medical affairs have previously interacted with pharma companies. For example, they may have given input on therapeutic areas either as consultants or serving on advisory boards. Lastly, entry level positions in pharma may require no prior experience.
The career portals of each pharma company will list current job openings, including those appropriate for physicians. Companies may work with recruiters that specialize in finding physicians interested in transitioning to positions in industry.
In general, people find jobs in the pharma industry through networking. When a position becomes available, physicians who work in industry will often reach out to colleagues that they think will be a good fit. Maintaining a good career network and a solid resume will open doors to pharma positions.
Last Notes on Physicians in Pharma
No matter their function or organization, physicians with positions in pharma and biotech will work on cross-functional teams. The matrix organization and nature of drug development in pharma require interaction and teamwork with other physicians, scientists, engineers, and those from a variety of different expertise.
Physicians must be willing and interested in learning about new scientific concepts. They will also need to understand corporate structures as well as business and regulatory issues. The short-term sense of achievement or gratitude that comes from individual patient care will likely be missing. Instead, physicians in the pharma industry must have the resilience to stay on track in the face of large years-long projects. Any attempt to bring a drug from the bench to the bedside will face competitive business and regulatory hurdles.
Start learning about the pharma industry here.
Pharma companies hire physicians who are passionate about drug development. Physicians who choose to join the pharma industry sign up for a career that can take them down many different interesting roads that will eventually have a broad impact on patients.
Are you a physician who is interested in transitioning to a job in pharma? Share your experience and questions in the comments below!