The Center for Biologics Evaluation and Research (CBER) is recruiting to fill multiple Medical Officer positions in a variety of specialties and subspecialties. Specialties include, but are not limited to: Internal Medicine, Cardiology, Oncology and Hematology, Infectious Disease, Neurology, Family Medicine, Emergency Medicine, Transfusion Medicine, Anesthesiology, Pediatrics, etc. Multiple positions are available throughout the various Center Offices to include: Office of Biostatistics and Epidemiology (OBE), Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Tissues and Advanced Therapies (OTAT).
Medical Officers serve as clinical experts in the review and evaluation of trials and clinical development programs for investigational biologic products for safety, biological activity, and efficacy. They have an important role in the approval process for biologic products by virtue of their extensive knowledge of clinical trial design and evaluation of results from a broad multidisciplinary background which allows for critical assessment of the rationale, safety, and adequacy of study design and interpretation of results. They advise and recommend action on Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), New Drug Applications (NDAs), Investigational Device Exemptions (IDEs), Pre-Market Approval Applications (PMAs), and/or 510(k) submissions. The specific duties and grade level of each Medical Officer position may vary depending on the selecting Office.
Must be U.S. citizen with Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) degree from a school in the United States or Canada approved by a recognized accrediting body in the year of the applicant's graduation. [A Doctor of Medicine or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States may be demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG) (or a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country)]. Candidates for Civil Service or U.S. Commissioned Corps must possess a valid license to practice medicine in any state in the U.S. Completion of residency training and fellowship program, with Board Certification or eligibility highly desired. U.S. Public Health Service Commissioned Corps Officers may also apply.
Please reference Job Code: CBER-17-0001-NHMA when responding to this job advertisement.
Additional Salary Information: Salary may be equivalent to GP-602-14 or GP-0602-15, plus physician market pay (Title 38), and commensurate with education/experience. Team Lead or supervisory positions may be filled through this advertisement, and a Peer Review package may be required depending on the position.
The Center for Biologics Evaluation and Research (CBER) is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them.