FDA's Center, for Drug Evaluation and Research (CDER) is searching for exceptional candidates for the position of Deputy Director of the Office of New Drugs (OND). The Office of New Drugs provides regulatory oversight for investigational studies during drug development. It 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.

 

This position offers a unique an exciting opportunity to lead a rapidly growing organization. The Office currently has over 1000 employees. The incumbent serves as a Deputy Director, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER) and as such exercises a high degree of medical expertise in fulfilling the duties and responsibilities of the position. As a Deputy Office Director, the incumbent is responsible for assisting in the overall management and direction of the Center’s broad national and international scientific and medical programs and activities related to the drug development and clinical trial design activities of all drug products for human use. Shares fully with the Office Director in all the responsibilities for the executive direction of a super office in CDER that has six subordinate Offices (Office of Drug Evaluation I, II, III, IV, OHOP and OAP). 

 

Applicants must possess an M.D. and/or Ph.D. in a hard science.

 

Successful candidates are those that have executive-level experience leading large scale organizations in multi-disciplinary teams and achieving outstanding results. The incumbent must have the ability to lead and manage a broad portfolio of projects and to successfully deliver high quality outcomes in a timely matter. A highly qualified candidate will possess 10+ years of experience in clinical drug development, including experience designing, conducting, and analyzing clinical trials to support new drug approval. They should have experience in benefit/risk analysis and be able to lead and manage in a team-based collaborative manner.

 

Location: Silver Spring, Maryland

 

Salary: Salary is commensurate with qualifications and experience. A full Federal benefits package is also available including: leave, health and life insurance, retirement, long term care insurance, and Thrift Savings Plan (401K equivalent).