Published by Lookforzebras
- The FDA does a lot more than you might realize
- FDA centers and offices where physicians can work
- FDA titles, roles, and responsibilities for physicians
- Benefits of a career with the FDA
There’s been a heightened interest in drug and vaccine safety among both healthcare professionals and the general public since the COVID-19 pandemic began. We want effective treatments and a vaccine as soon as possible, but we also want these to have risk and toxicity profiles that are acceptable. The US Food and Drug Administration (FDA) has the important and challenging task of making sure both of these criteria is met for all drugs and vaccines. Doing so requires medical knowledge and clinical acumen. As a result, there are FDA jobs for physicians.
The FDA, however, does a lot more than approve investigational drugs and vaccines. And there is a lot more that doctors are needed for than solely reviewing clinical trial results. There is actually an impressive array of nonclinical FDA career paths that medical professionals can take within the agency.
The FDA does a lot more than you might realize
The FDA affects the lives of nearly all Americans on a daily basis. It is responsible for the safety and regulation of most types of foods, drugs, vaccines, blood products and biological medical products, medical devices, dietary supplements, radiation-emitting devices, veterinary products, and cosmetics. A frequently cited statistic is that FDA-regulated products account for about 20 cents of every dollar spent by US consumers.
To accomplish this, the FDA runs on an annual budget of over $4 billion and employs over 15,000 staff. Many of these staff members are scientists and doctors. While it’s not a requirement that the agency be led by a physician, all but two FDA Commissioners since the mid-1960’s have been MDs.
FDA centers and offices where physicians can work
Let’s delve into what physicians who work at the FDA contribute to the agency and, subsequently, the health and safety of Americans.
Drug Evaluation and Research
The FDA’s Center for Drug Evaluation and Research (CDER) has one of the highest concentrations of medical doctors in the agency. CDER’s capacity most closely aligns with what we typically think about when we hear “FDA.” That is, the safety and effectiveness of medications that make it to the market.
Clinical trial data review and new drug approvals are major parts of the work of many physicians who work at CDER. But, as mentioned above, the FDA’s doctors do a lot more than this – even those working within CDER.
When it comes to drug regulations, FDA Medical Officer jobs can involve review of:
- Applications for approval of new medications
- New indications for previously approved drugs
- Advertising, promotional materials, and drug labeling
- Post-market safety surveillance data
- Generic drugs
- Over-the-counter drugs
The initial approval of a new drug isn’t the end of FDA’s involvement with the drug. They regulate the entire lifestyle of a drug product, ensuring its safety as real world data becomes available and other medical advancements and discoveries are made.
Biologics evaluation and research
As doctors, we treat our patients with a lot more than just drugs. We use blood and tissue products, biologics, vaccines, and other products derived from living sources or manufactured using biotechnology. This is where the Center for Biologics Evaluation and Research (CBER) comes into play. Physicians are needed for CBER’s regulatory oversight in a similar way that they’re needed for CDER’s.
Medical devices and radiological health
Scientists and doctors working in the Center for Devices and Radiological Health (CDRH) ensure the safety and effectiveness of devices. These include over 6,000 types of devices, ranging from surgical masks to implants to life-sustaining machines, chambers, and apparatuses.
A doctor in this capacity might evaluate the methods used for product testing, determine the scientific significance of data submitted by a device company, apply clinical expertise to review product data, and provide guidance on issues pertaining to device safety and efficacy.
Food safety, food policy, and applied nutrition
With their knowledge of physiology, pathology, and biochemistry, physicians have a lot to offer the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). They can provide authoritative medical and epidemiological advice, guidance, assistance, interpretation, and recommendations regarding food safety. This includes not just the food itself, but also its additives, labeling, and associated outbreaks and incidents.
Medical Officers involved in food safety with the FDA also work to promote collaboration with multiple partners from within and outside the agency, including laboratory, public health, agriculture, and regulatory partners at the state and local level.
The Center for Tobacco Products (CFT) carries out the 2009 Tobacco Control Act, which gave the FDA broad authority to regulate the manufacturing, distribution, and marketing of tobacco products. This gives physicians who work at FDA the ability to help protect Americans from tobacco-related death and disease.
A Medical Officer with the CFT serves as an expert in the health implications of tobacco product use. This includes evaluating clinical studies, product use initiation and cessation, adverse health impacts, and analysis of morbidity and mortality data, which can then be used to establish strategy for the Center.
Transdisciplinary and cross-divisional FDA jobs for physicians
Not all FDA jobs for physicians are focused on a single type of product that the FDA regulates. Doctors play an important role in overall leadership for the agency in a variety of ways. For example, I did a rotation at the FDA as a resident during which my preceptor (an MD) was the Acting Associate Commissioner for Policy and Planning. He had a broad – but incredibly interesting and scientifically-grounded – role with the agency.
Here are a few of the FDA Offices where physicians seeking nonclinical positions may find a niche:
- Policy, Legislation, and International Affairs
- Clinical Policy and Programs
- Women’s Health
- Minority Health and Health Equity
In these positions, physicians might be involved with scientific integrity, health informatics, lab safety and regulatory innovation, and even countering bioterrorism.
FDA titles, roles, and responsibilities for physicians
So far, we’ve covered the various centers and offices in which FDA physicians have a place. But what roles do doctors actually hold?
FDA Medical Officer jobs
FDA Medical Officer jobs are the most common role for physicians at the agency. In most cases, Medical Officers also have more descriptive title for their role, such as:
- Primary Clinical Reviewer
- Guidance and Policy Writer
- Labeling Reviewer
- Safety Officer
A Medical Officer who works as a clinical reviewer provides subject matter expertise in the review of product submissions. He or she might shape clinical trial requirements for an investigational drug, review complete trial data, and make recommendations for approval or requests for additional studies from the sponsor.
Physician reviewers are likely to have frequent meetings with their Team Lead as well as with the drug companies sponsoring investigational agents. They also have the opportunity to provide guidance and training about clinical trial design and drug development.
FDA career paths – What comes after Clinical Reviewer?
Physician Reviewers who advance within the organization often become leaders and supervisors. The Clinical Team Lead or Lead Medical Officer oversees a team of reviewers within a therapeutic area.
From there, a physician might become the Deputy Director or Director of an entire program. As a Director, physicians provide strategic planning and lead the development, execution, and evaluation of various programs. Examples of FDA programs led by physician Directors include:
- Emergency Preparedness/Operations and Medical Countermeasures
- Rare Diseases Program
- Therapeutic Performance of Generic Drugs
- Personalized Medicine Program
For those who stick with it and work their way up in the agency, the FDA has a number of executive-level positions fitting for medical doctors that encompass a variety of disciplines.
FDA jobs for physicians and non-physicians who aren’t qualified to be Medical Officers
If you didn’t complete a residency, don’t have an MD, have been out of practice for a while, or are otherwise not qualified for a Medical Officer position with the FDA, there are some great options for you!
There are many scientific positions with the FDA that don’t require medical training. The agency hires biologists, chemists, epidemiologists, nurses, pharmacists, pharmacologists, social and behavioral scientists, statisticians, veterinarians, engineers, and others.
These are few examples of scientific positions that earn well over 6-figures but that don’t require a medical degree:
- Consumer Safety Officer
- Research Microbiologist
- Health Scientist
- Public Affairs Specialist
- Regulatory Director
Despite these being positions that are not specifically for physicians, much of the work in these jobs will utilize parts of medical training and clinical experience that you may have.
Options for doctors in training
Finally, there are ways for medical students, residents, and early-career physicians to get a taste of an FDA career without taking a full-time position. Here are a few to check out:
- The prestigious Commissioner’s Fellowship Program
- The Summer Student Research Program at the National Center for Toxicological Research\
- The Tobacco Regulatory Science Fellowship
- The Oncology Center of Excellence Fellows Program
- Several fellowship and training programs administered by the Oak Ridge Institute for Science and Education
Benefits of a career with the FDA
Yes, there are drawbacks to working for the government. The salary for many physicians will be somewhat lower than they can make in private practice. There is government bureaucracy to deal with. And the FDA is consistently in the public spotlight, frequently getting criticized both for being perceived as too tough on industry and also deficient in ensuring the safety of drugs.
However, there are many benefits to FDA jobs for physicians.
Meaningful work. As described above, you help to ensure the health and safety of our population.
Use your medical degree and training. Succeeding in an FDA Medical Officer job requires leaning heavily on your knowledge of clinical medicine and its scientific basis.
Work with smart, passionate people. There is an extremely high density of bright, highly-trained scientists at the FDA. The majority are passionate about the work that they do.
Government job benefits. These include generous standard employee benefits, such as health and disability insurance, but also other benefits like professional development opportunities.
Gain experience for a pharma job. Experience working with the FDA is a sought-after background for physicians wishing to take jobs in the pharmaceutical industry.
Good hours and work flexibility. There is typically no requirement to work on weekends or take call. Many Medical Officers have a good deal of flexibility in their work schedule and have the option to spend at least a portion of their time working from home.
Start your search for FDA Medical Officer jobs and other FDA careers
My hope is that some readers have been inspired to learn more about an FDA career path or even start searching for FDA job vacancies. If you’re considering transitioning your career to nonclinical work or seeking an alternative way to use your medical training, here are a few steps you can take to further explore the option of working in food and drug safety:
Search for openings on USAJobs. USAJobs.gov is the official job listing site for federal government jobs. You can filter your search results by agency to narrow in on FDA Medical Officer jobs.
Peruse the Look for Zebras job board and sign up for The Stampede. The L4Z job board has included FDA job vacancies from time to time, and frequently lists jobs for physicians in the pharmaceutical industry. Sign up for our email list to receive The Stampede, which is a weekly email digest of new job postings.
Read more about nonclinical careers. My book 50 Nonclinical Careers for Physicians has a section about jobs for physicians with the US Health and Human Services (which includes the FDA). It also includes an interview with an FDA Clinical Team Leader.
2 thoughts on “FDA jobs for physicians—much more than approving new drug applications!”
Are there any part time MD consultant positions available?
I know that some folks do work as consultants for the FDA. But – like many consulting positions – these opportunities don’t seem to get posted publicly, at least from what I’ve seen.
Comments are closed.