The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.

A Day in the Life:

As an infectious disease expert for the FDA, you will review new drugs to ensure that they’re safe and effective.

• Before testing on humans: You will check if the drug’s design is sound and backed by strong animal testing.
• For approval: You will evaluate clinical trial results and labeling accuracy to ensure the drug works as intended and has clear instructions and warnings.
• For existing drugs: You will review updates, safety reports, and potential new uses or label changes.

You will work with your team to make evidence-based decisions.

• You will analyze summaries from other experts and recommend approving, requesting more data, or rejecting applications.
• You will consult with other specialists to address complex issues and stay up to date on scientific advancements.
• You will share your expertise through conferences and publications.

Position Requirements:

Education:

• US or Canadian Medical Degree: MD, DO, or equivalent from an accredited school.
• Foreign Medical Degree: MD or equivalency, such as a ECFMG certification or USMLE completion.

Licensure:

• Current, active, full, and unrestricted medical license in the US or its territories.

Needed Experience:

• Ability to apply clinical and scientific knowledge to complex medical problems and benefit/risk management.
• Enjoys solving unique problems and addressing challenges in drug/biologic regulatory review.
• Desire to stay current on the latest clinical information in your assigned therapeutic area.
• Capable of strong written and verbal communication.

The Food and Drug Administration (FDA) is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.

The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over the counter and prescription drugs, including biological therapeutics and generic drugs.

AE Strategies   has provided human capital management consulting to federal clients for the past 20 years. We are proud to be partnered with the FDA to assist with their recruiting needs.