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Director, Division of Clinical Outcomes Assessment

Employer
FDA's Office of New Drugs
Location
Silver Spring, Maryland
Salary
Up to $200,000 (or more) per year + excellent federal government benefits package
Closing date
Oct 22, 2019

Job Details

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 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: 20-023EG.

Company

FDA is an agency within the Department of Health and Human Services.

The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations.

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

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