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Are you making an outsized difference to the public health and well-being of Americans? Would you like to? The physicians, scientists and other dedicated professionals at the U.S. Food & Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs located in Silver Spring, MD, contribute to the public health of millions of Americans every day. We pride ourselves on our dedicated and skilled staff and are looking for committed individuals to help us achieve our mission. OND’s mission is to ensure that safe and effective drugs and biologics are available to Americans. We provide guidance to drug companies on a wide variety of clinical, scientific, and regulatory matters and make decisions on whether new drugs or new uses of already marketed drugs should be approved.

The Division of Rare Diseases and Medical Genetics within the Office of New Drugs is seeking highly qualified physicians to serve as clinical reviewers for drugs that treat rare, inborn errors of metabolism. We are seeking individuals who are board certified or board eligible in a primary care field (pediatrics/internal medicine/family medicine/other) and/or in medical genetics and genomics. We are particularly interested in individuals with expertise and/or interest in rare diseases such as inborn errors of metabolism and other inherited conditions.  Graduating fellows and junior faculty are encouraged to apply. 

Primary responsibilities of the clinical reviewer include the following:

• Determines whether clinical trials of new drugs and therapeutic biologics in humans are soundly conceived and supported to justify human testing
• Reviews clinical protocols and provides input regarding study design
• Together with other team members, interacts with investigators and drug companies to guide development of drugs and therapeutic biologics
• Determines whether marketing applications should be approved based on an evaluation of the evidence of safety and effectiveness
• Consults, when needed and where appropriate, with other medical specialists and scientists within and outside FDA
• Assists in the development and conduct of training programs, educational activities, workshops and conferences
• Keeps abreast of the progress in medical and related sciences by reviewing the scientific literature and participating in staff seminars where cases and topics of interest are discussed 

As a clinical reviewer, you will have the opportunity to:

• Advance the public health through new drug development;
• Experience teaching and training opportunities;
• Interact with pharmaceutical companies, world-renown disease experts, patients and advocacy groups; and
• Work with a wide range of scientific disciplines in a team-oriented atmosphere. 

This position allows for one half-day per week of patient care, if interested. 

SALARY & BENEFITS 

• Salary is commensurate with experience and expertise
• Excellent federal government benefits package (health insurance, life insurance, retirement, etc.).
• Relocation expenses and student loan repayment may be paid to eligible candidates.
• Flexible and/or partial telework schedules available (after completion of initial training period).

QUALIFICATIONS 

Applicants must have a Doctor of Medicine or Doctor of Osteopathy degree from an accredited medical school. Graduates of foreign medical schools must be certified by the Education Commission for Foreign Medical Graduates. Candidates must be U.S. citizens. Permanent U.S. residents may apply for staff fellowship appointments. Excellent oral and written communication skills and an ability to work effectively in a team are necessary to be successful in this role. A competitive candidate will have experience working with clinical data with enough knowledge and understanding of clinical trial design to evaluate extensive, long-range scientific programs, and their implications on the drug development process. Prior human subject research experience is desired, but not required. 

TO APPLY

Please send a current CV/resume and cover letter to ond-employment@fda.hhs.gov for consideration. Please reference source code: #23-011EG in the subject line.

About FDA's Office of New Drugs

FDA is an agency within the Department of Health and Human Services. The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations. The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

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