Home / Job Listings / Associate Director of Biosimilar Review at the U.S. Food and Drug Administration

Associate Director of Biosimilar Review at the U.S. Food and Drug Administration Posted 05/01/2018

The mission of the Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, is to protect public health by assuring the quality, safety, efficacy, availability, and security of therapeutic protein and monoclonal antibody products. OBP’s laboratory research programs investigate the structure, manufacture, and molecular actions of protein-based drugs in order to inform science-based regulatory standards and review activities.

OBP is seeking to recruit a qualified and motivated individual, with Ph.D. and/or M.D. degree, for a Title 42(f) executive position.

As the Associate Director for Biosimilar Review, the incumbent is responsible for the development and consistent application of appropriate methods and approaches for the review of biosimilar products, including evaluation of analytical similarity. The Associate Director formulates the policies and procedures to ensure high quality reviews of biosimilars across therapeutic areas; Serves as the OBP key resource and focal point in the development and implementation of best practices for biosimilar reviews; Actively participates in the Biosimilar Review Committee meetings and deliberations; Actively engages with Division Directors and review management to ensure adequate resources are available for the timely  completion  of  biosimilar  reviews  and  monitors  recruitment  efforts  in  this regard.

The Associate Director for Biosimilar Review Serves  as  the  principal  advisor  to  the  Office  Director  on  all  matters  concerning quality reviews of biosimilars, including identification of key areas where further guidance development is needed. The Associate Director assumes responsibility with office policy management for the Office’s contributions to multi-disciplinary guidance documents relating to biosimilar product reviews and provides oversight to the writing teams for guidance documents generated by the Office of Biotechnology Products in this area; Develops and implements a comprehensive training program for quality reviewers involved in the review of biosimilar products. These duties require the Associate Director to develop and maintain relationships with regulated industry, academia, and Center/Agency managers and staff to continually guide OBP in the application of state-of-the-art methodologies for the evaluating quality and analytical similarity.

Position located in Silver Spring, MD.

Open to U.S. citizens only.

All applications need to be submitted to CDER-OBP-Recruitment@fda.hhs.gov

The Food and Drug Administration is an Equal Opportunity Employer.

Related articles

Comments (0)