The Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER), located at the White Oak campus in Silver Spring, MD is recruiting Social Science Analysts, Clinical Analysts and Pharmacists to serve as experts in the evaluation and use of Clinical Outcome Assessments in the dynamic, challenging, and innovative atmosphere of drug development and research.
Selected candidates will join the Clinical Outcome Assessments (COA) Staff where they will contribute to a culture that ensures the patient voice is integrated into drug development through clinical outcome assessment endpoints that are meaningful to patients, valid, reliable, and responsive to treatment across a variety of therapeutic areas. COA Staff members provide advice and consultation on endpoint development, validation, interpretation, and representation in drug product labeling to both the OND review divisions as well as to external submitters of COAs for qualification.
Team members also have the opportunity to participate in guidance and policy development and implementation to ensure that meaningful drug product information is available to health care providers, caregivers, and patients.
Team members interact with many levels of Center management, as well as other Agencies within the Department of Health and Human Services, pharmaceutical industry representatives, academia, patient advocacy groups, and the public.
SALARY & BENEFITS: Salary is commensurate with education and experience. We offer an excellent benefits package (health insurance, life insurance, thrift savings plan, retirement). We offer flexible work schedules and many opportunities to continue professional development.
BASIC REQUIREMENTS: Must hold a M.S. or Ph.D. in the allied health sciences, social sciences, or health outcomes/ health services research OR hold a Doctor of Pharmacy OR hold a Doctor of Medicine or Doctor of Osteopathy from an accredited school in the United States or Canada, or equivalent.
INTERESTED CANDIDATES: Please contact COAStaff@fda.hhs.gov for more information about the COA Staff please refer to the COA Staff internet website:
The Center for Drug Evaluation & Research (CDER) at the Food and Drug Administration (FDA) carries out an essential public health mission by ensuring that safe and effective drugs are available to improve the health of the American people. The Office of New Drugs in CDER is the nexus where this oversight of drug development and review takes place. We advance public health by helping to bring new product innovations to market. Our work begins when pharmaceutical manufacturers prepare to begin clinical testing of their new products. We ensure the safety of patients in clinical trials and provide advice to manufacturers on the design and conduct of the trial and the analysis of the trial results. Our work continues when development of the product is complete and the manufacturer seeks approval to market the product. We evaluate and analyze the evidence of the drug’s safety and effectiveness to determine whether the new product meets FDA’s standards for approval. As part of this review, we also play a critical role in ensuring that healthcare professionals and patients have accurate science-based information so that new drugs are used safely and appropriately. Following approval, we co...ntinue to monitor marketed products to ensure their continued safety as they are used in a broader patient population.Our work in OND impacts the lives of Americans on a daily basis. We rely on experienced physicians and other highly qualified and dedicated professionals to carry out our important mission. OND operates in a team-based, collegial environment where our staff interacts with various scientific disciplines (e.g., statistics, clinical pharmacology, chemistry) that are all involved in drug regulation. Many opportunities also exist to provide scientific leadership through collaborative work with the pharmaceutical industry, academia, and other domestic and foreign regulatory agencies and other organizations. With the increasingly rapid development of new therapies that improve the lives of patients here and abroad, this is an exciting time to be part of the drug development and review enterprise.