Director, Office of Therapeutic Products

The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) is actively recruiting an individual to serve as the Super Office Director for the Office of Therapeutic Products (OTP). OTP oversees the development and regulation for a wide variety of products, including cells, tissues, and gene therapies, protein products derived from blood and their recombinant analogues, along with certain medical devices used in the production of these products. In addition to regulatory review of product quality, safety, and effectiveness, the Super Office conducts applied scientific research related to the products that it regulates, contributes to the development of relevant regulatory policy, and supports other agency and center components involved in ensuring compliance with agency biologics regulations. The Super Office Director of OTP in CBER will be responsible for, but not limited to, the following duties:

• Oversees the various offices and programs within the Super Office, which involves applying a science-based approach in support of regulatory decision-making regarding clinical applications, the conduct of applied scientific research, and the development of regulatory policy; supports compliance and enforcement activities related to regulated products; collaborates with other Center and Agency units requiring expertise in therapeutic product evaluation.
• Supervises the various Office Directors and the Immediate Office in planning, managing, organizing, and directing regulatory review operations, and research activities of the Super Office as carried out by the Office Directors and highly trained and skilled staff.
• Advances new policy initiatives related to regulated products, proposing and developing guidance, changes in regulations, and legislative initiatives, as appropriate, based on the emerging science.
• Directs the implementation of new laws and regulations which affect the mission of the Super Office including initiating and implementing new policies, systems, procedures, and organizational structures.
• Applies administrative and program management principles and skills to carry out the mission of the Super Office and addresses and solves challenging and often precedent- setting problems.
• In consultation with the Center Director, initiates and participates fully in discussions and decisions concerning Super Office plans, programs, and activities, both in strategic planning and implementation.

Area of Consideration: Candidates must be a U.S. Citizen or U.S. National.

Desired Education: Medical degree plus a research doctoral degree such as a PhD

Location: Silver Spring, Maryland

Salary: $250,000 - $355,870

Application Procedures: Submit electronic resume or curriculum vitae, unofficial transcripts (if applicable), medical license/s, board certification/s (if applicable), SF-50 (if applicable), latest signed PMAP (if applicable), and letter of interest with “CURES CBER/OTP Super Office Director” in the subject line to: CBERHumanCapital@fda.hhs.gov.