Director, Office of Drug Evaluation Sciences
The Office of New Drugs (OND) is recruiting to fill the position of Director, Office of Drug Evaluation Sciences.
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.
Within OND, the (sub) Office of Drug Evaluation Sciences (ODES) provides direction and guidance on the design and application of endpoints and instruments (e.g., biomarkers/surrogate endpoints, clinical outcome assessments (COA), bioinformatics) that support drug development, provides direction and guidance on safety analytic tools and approaches, and supports research in OND relevant to drug development and regulation. ODES provides support across OND therapeutic divisions, in collaboration with other offices in the Center for Drug Evaluation and Research and other FDA centers, and works closely with external stakeholders including patient, academic, and industry organizations to advance methods and tools supporting drug development and review.
The ODES Directorship represents an extraordinary opportunity for an exceptional leader to meet the challenges of emerging science at the crossroads of drug development.
The selected candidate will possess a demonstrated track record of thought leadership in a field relevant to the broad range of ODES responsibility (such as COA or biomarker development); drug development experience in academia, government, or industry; experience building multidisciplinary teams to collaborate across a heavily matrixed environment and achieve strategic objectives; 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 email@example.com. To apply, submit your cover letter and CV/resume to firstname.lastname@example.org. Please indicate that you are applying to source code: 20-026EG.
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