Office of Tissues and Advanced Therapies (OTAT)
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
FOOD AND DRUG ADMINISTRATION (FDA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT) is seeking a Board Eligible/Board Certified Neurologist to serve as a Physician in our Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT).
The incumbent will be a member of an interdisciplinary team of scientists, physicians, and support personnel in OTAT. The team is responsible for the evaluation of safety and effectiveness of investigational and previously licensed biologics and for enforcing safeguards for testing of experimental biologics in humans intended to treat a variety of neurological and other non-oncology/hematology conditions. Associated with these primary functions are activities concerned with review and regulation of labeling and advertising, evaluation of adverse events, advancement of research and evaluation of practices, and development of policy as expressed in regulations and guidance documents.
The incumbent will review Investigational New Drug Applications (INDs) for evaluation of the proposed clinical trials for safety, appropriateness of the study population, and other study design elements. The incumbent determines if human subjects in clinical research with investigational advanced therapy products, such as cellular and gene therapies, can be protected from unreasonable risks, and ascertains whether such trials are of adequate and appropriate design to permit collection of the necessary evidence to determine the safety and effectiveness of the investigational products.
The incumbent will be involved in internal and sponsor-attended discussions to assess the readiness of the clinical data for submission of a biological license application (BLA). Once a BLA is submitted, the incumbent will play a significant role in the evaluation of the clinical portion of the BLA.
BASIC QUALIFICATIONS: Physician, GP-0602: Must be a U.S. Citizen with Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.) or equivalent degree from a school in the United States or Canada. – OR – 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 (ECFMG). For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.
LICENSURE: 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.
ADDITIONAL REQUIREMENTS: At least 4 years of postgraduate neurology residency training or equivalent experience. Training in regulatory science and/or medical research is a plus but not a requirement.
SALARY: Salary is equivalent to GS-0602-14, plus physician market pay (Title 38), and is commensurate with education/experience. U.S. Public Health Service Commissioned Corps Officers may also apply. An excellent benefits package including flexible workplace options and paid professional development including time for clinical practice is also available.
LOCATION: FDA White Oak Campus in Silver Spring, MD
HOW TO APPLY: To apply for this position within CBER, please complete the following steps:
- Please submit your electronic resume or curriculum vitae, copy of active medical license, copy of transcripts (unofficial), letter of interest, and supporting documentation to CBER Recruitment at CBER.Employment@fda.hhs.gov and carbon-copy Dr. Lei Xu at email@example.com. Supporting documentation may include: bibliography, summary of research accomplishments, and names/contact information of three references. Please reference Job Code: OTAT-22-14-NEU.
- Create/Log-in to your USAJOBS account and apply to the official Physician GP-0602-14 job opportunity announcement located on USAJobs.gov at https://www.usajobs.gov/job/636152100. For consideration, applications MUST be received by applying to the official job opportunity announcement located above.
DEPARTMENT OF HEALTH AND HUMAN SERVICES IS AN EQUAL OPPORTUNITY EMPLOYER WITH A SMOKE FREE ENVIRONMENT