Pharmaceutical physicians in clinical trial and drug development often work in conjunction with a host of other professionals including PhD researchers, marketers, chemists, pharmacists, and others to ensure that drugs in clinical trials that will soon come to market are safe and efficacious. Physicians working in clinical research help to advance the field and allow patients to access the latest medical treatments, diagnostics, and other products. They offer the unique perspective of having worked in clinical medicine. Their contribution is enhanced by understanding clinical indications, side effects, treatment plans, and how to approach medical conditions.
Clinical research and drug development positions exist in academia, clinical research organizations, pharmaceutical companies, or as independent consultants providing knowledge to any of these organizations or privately held companies.
Clinical Research Physician
▪ Meet with regulatory agencies regarding clinical trials
▪ Provide medical input for clinical trial design
▪ Contribute to clinical trials operations and oversight
▪ Meet with various departments to discuss barriers to drug development
▪ Interact with regulatory bodies to investigate counterfeit medications
▪ Discuss product labeling
▪ Register new medications and receive approval of promotional materials
▪ Review new clinical data or adverse events reports
▪ Discuss drug side effects or concerns with physicians
▪ Travel to conferences to learn about new areas of drug discovery and development
▪ Clinical Research
▪ Organizations (CROs)
|▪ Biopharmaceutical companies|
▪ Independent consultant
▪ Pharmaceutical company
Job responsibilities in the field of drug development can include participating on clinical research teams, interacting with institutional review boards, consulting for biopharmaceutical development departments, and numerous other roles.
Various job responsibilities may include:
- Evaluating the efficacy of new treatment regimens in patients
- Providing medical input for clinical trial design and ensuring that the trials run smoothly
- Meeting with regulatory agencies regarding clinical trials
- Traveling to conferences to learn about new areas of drug discovery and development
- Discussing drug side effects or concerns with physicians
- Reviewing data on a drug to collaborate on similar but improved treatments
- Meeting with various departments to discuss barriers to drug development
- Interacting with regulatory bodies to investigate counterfeit medications
- Discussing product labeling
- Developing new medication labeling and approving promotional materials
- Reviewing new clinical data and adverse events reports
- Providing clinical input and oversight in various phases of drug development
Work Environment and Schedule
Work environment can vary highly based on the specific role type. Positions can include supervisory roles in laboratory environments, office based work with normally scheduled hours, or consultant work with variable travel, schedule, and workload.
In contrast to research performed in academia, which at times can be bureaucratic and slow to initiate, clinical research organizations often have set procedures in place that keep them running efficiently. Physicians that truly enjoy clinical research and have a desire to investigate new treatment modalities can work in a variety of investigatory or supervisory roles in clinical research and drug development.
Required Skills and Training
For physicians who have already worked in areas of clinical or scientific research, a transition to clinical trial research and drug development may be natural and unproblematic, although there may be many more regulations and procedures to adhere to. Physicians from subspecialty areas may be able to consult or work for clinical research organizations studying and developing drugs in their specialized field of expertise.
Required skills include:
- Degree in a science-related field
- For supervisory positions, PhD, MD, or advanced degrees are generally required
- Understanding of research methodology and biostatistics
- Interest and comprehension of pharmacologic principles including pharmacodynamics and pharmacokinetics.
Residency, Licensure, and Training Requirements
The requirements for post-graduate training are variable, depending on the role. Some positions do not require a residency; however, having completed a residency will improve your chances of being hired. Positions in a specialized area of drug development typically require specialty training. An active license is not generally needed.
Is This a Career for You?
Physicians with an interest in research design, medical clinical trial development and supervision, and promotion of new and innovative treatments and drugs may find a career in clinical trials or drug development to be intellectually stimulating and rewarding. Those with an interest in working on new and innovative drugs, drug safety, and enhancing our understanding disease processes may enjoy the intellectual stimulation that comes from working in clinical research and drug development.
Physicians who do not enjoy research methodology, regulations, or pharmacology may not be suited for a career in clinical trials and drug development. For someone who enjoys some of the components of pharmacology, but does not want to conduct or advise on the trials, a career in scientific writing may allow them to provide assistance in drug approval processes.