Director, Division of Research and Biomarkers Development

The Office of New Drugs (OND) is recruiting to fill the position of Director, Division of Research and Biomarkers Development (DRBD).

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.

DRBD oversees OND scientific research programs to inform regulatory decision making; provides scientific leadership and technical advice concerning biomarkers and surrogate endpoints; collaborates with academic scientists, industry, patient groups, governmental partners and other stakeholders concerning biomarker and surrogate endpoint development; and manages the Biomarker Qualification Program.

The DRBD Directorship represents a unique opportunity to accelerate and enable drug development in areas of unmet need globally.

The selected candidate will be a leading expert on the development of biomarkers and surrogate endpoints and application of biomarkers/surrogates to facilitate clinical research, have a strong background in clinical translational research, possess 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 any questions concerning the position to the OND External Recruitment Team at ond-employment@fda.hhs.gov. To apply, submit your cover letter and CV/resume to ond-employment@fda.hhs.gov. Please indicate that you are applying to source code: 20-038EG.