Director, Division of Clinical Outcomes Assessment
The Office of New Drugs (OND) is recruiting to fill the position of Director, Division of Clinical Outcomes Assessment (DCOA).
OND ensures that safe and effective drugs and biologics are available to the American people. OND provides regulatory oversight for investigational studies during drug development, makes decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products, and provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.
DCOA leads policy development and provides technical advice to OND therapeutic divisions and other FDA staff about the design, implementation, and analysis of Clinical Outcome Assessment (COA) instruments for use in drug development with a focus on endpoints relevant to regulatory decision-making and labeling and manages the COA Qualification Program.
The DCOA Directorship is a unique opportunity to shape scientifically rigorous, fit-for-purpose COA methodologies to enhance patient focused drug development. The selected candidate will possess expertise in COA design, implementation, and analysis in drug development; and strong organizational and program development skills and must have a Doctor of Medicine or Doctor of Osteopathy degree from an accredited medical school. Graduates of foreign medical school must be certified by the Education Commission for Foreign Medical Graduates (ECFMG). Candidates must be U.S. citizens.
Interested candidates may direct questions concerning the position to the OND External Recruitment Team at firstname.lastname@example.org. To apply, submit your cover letter and CV/resume to email@example.com. Please indicate that you are applying to source code: 20-023EG.