DIVISIONDIRECTOR, DIVISION OF EPIDEMIOLOGY (DE) TITLE 38(F) SUPERVISORYPHYSICIAN (GP-0602-15)
OFFICE OF BIOSTATISTICSANDEPIDEMIOLOGY (OBE) CENTERFORBIOLOGICSEVALUATIONANDRESEARCH (CBER) FOODANDDRUGADMINISTRATION (FDA)
The Center for Biologics Evaluation and Research (CBER) is recruiting to fill a Supervisory Physician, GP-0602-15 position to serve as the Director of the Division of Epidemiology (DE) in the Office of Biostatistics and Epidemiology (OBE).
The Division of Epidemiology in CBER/OBE studies and monitors the safety of a diverse portfolio of important and innovative biological products, including vaccines, blood products, gene therapies, human tissues, and cellular therapies. As Division Director, the selected candidate is responsible for the following: planning, developing, executing, and managing the Division's activities; collaborating with heads of other programs in CBER to negotiate, decide on, and coordinate work-related changes; and supervising employees graded GS-15 (or equivalent) and GS-14, which includes group leaders, Physicians, Epidemiologists, and administrative personnel. The Director manages Medical Officers and Epidemiologists who monitor post-market adverse event reports for biologics, drugs, and devices regulated by CBER, analyze epidemiologic safety data from controlled trials and observational studies, and participate in pre-licensure reviews of applications for new products. The Director’s work frequently includes collaboration with colleagues in other federal agencies, industry, and academia. Other duties include management and oversight of reporting to federal advisory committees, publishing in peer-reviewed journals, and serving on interdisciplinary FDA workgroups.
DESIRED KNOWLEDGE AND EXPERIENCE:
Broad knowledge and understanding of pharmacovigilance, pharmacoepidemiology, and the safety of biological products
Ability to lead and manage others engaged in scientific activities pertaining to epidemiology, surveillance, and regulatory review
Experience and knowledge related to the safety of biological products and the spontaneous reporting of adverse experiences associated with biological products
Must be a U.S. citizen with Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.) or equivalent from a school in the United States or Canada. The degree must have been accredited by the Council on Medical Education of the American Medical Association; Association of American Medical Colleges; Liaison Committee on Medical Education; Commission on Osteopathic College Accreditation of the American Osteopathic Association, or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (external link), a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country, or successful completion of the U.S. Medical Licensing Examination.
For all grade levels and positions, applicants must possess a current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. Candidates must also possess 5 years of graduate-level training in the specialty of the position to be filled or equivalent experience and training.
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. CBER also provides the public with information to promote the safe and appropriate use of biological products.