The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) located at the Food and Drug Administration (FDA) is recruiting to fill the position of Director, Office of Safety and Clinical Evaluation (OSCE). The Office of Generic Drugs (OGD) is responsible for the development and implementation of standards for the safety and effectiveness of generic drugs; reviews and evaluates Abbreviated New Drug Applications (ANDAs) and their amendments or supplements and determines approvability; establishes bioequivalence specifications for drug products and develops guidelines for bioequivalence reviews, industry protocols, and studies; and oversees all aspects of labeling submissions for ANDAs.
Manages a multi-disciplinary program. Provides leadership and management oversight to approximately 80 subordinate support staff and division directors performing the work and functions of the organizational unit. Provides occupational specific technical and administrative direction and supervision 25 percent or more of the time. Supervises a staff of scientists that provide clinical and scientific expertise in the evaluation of complex generic drug review issues. Obtains resources and identifies strategic objectives for the organization.
As the Office Director, oversees the Immediate Office and three Divisions in the OSCE, which includes; the Division of Clinical Review that assesses bioequivalence studies with comparative clinical endpoints and protocols supporting ANDAs and amendments and supplements; the Division of Pharmacology/Toxicology Review, which assesses the safety of generic drug formulations; and the Division of Clinical Safety and Surveillance which facilitates broad postmarket safety surveillance review and collaborative projects; coordinates the review of risk evaluation and mitigation strategies for ANDAs as well as conducts Bio-Investigational New Drug (IND) evaluations.
Serves as principal advisor to the OGD Director and other CDER leaders on safety and clinical evaluation activities that affect Office/Center generic drug programs, projects, and initiatives. Works collaboratively with the OGD Director and other leaders in OGD to formulate and set the Office’s strategic direction for clinical assessment and differences between the generic drug and its reference listed drug (RLD).
Oversees and directs the implementation of timely assessment of ANDAs submitted under section 505(j) of the Federal Food, Drug, and Cosmetic (FD&C) Act on bioequivalence standards for generic drugs with attention to coordinating complex scientific considerations.
Doctor of Medicine, Doctor of Osteopathic Medicine or equivalent from a school in the United States or Canada. This 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.
Degree from Foreign Medical School: 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, 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.
Licensure: 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.
Vacancy Type: Full Time
Job Location: New York, NY, US
Application Deadline: N/A