Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)
Strategic Vision and Leadership
- Serves as the driving force in the development and operations, of the generic drug program in CDER.
- Serves to coordinate and integrate the efforts of OGD subordinate offices and other CDER offices in operationalizing GDUFA activities.
- Represents and participates as the CDER expert in discussions, meetings and conferences with top officials from FDA and the U.S. Department of Health and Human Services, CEOs and other senior-level industry representatives with regard to generic drug issues and GDUFA implementation.
- Extensive interactions with representatives of the generic drug industry, academia, other federal agencies, and other Centers within the Agency in an effort to build CDER’s generic drug program presence.
- The Deputy Director reports to the OGD Office Director.
- Provides support and guidance in the development and the implementation of CDER’s generic drug program’s initiatives including GFUDA implementation
- Participates fully in planning, managing, organizing and directing all regulatory review operations, program segments, functions and activities of the Office including the formulation and establishment of Office policies and goals, determination of organizational and budget requirements, preparation of the budget and allocation of Office resources necessary to accomplish the regulatory review mission of the Office
- Responsible for staffing and organizing OGD, as well as recruiting and retaining the high-quality staff needed to manage the creation, development, and implementation of a broad array of specific, innovative cross-Center scientific activities necessary for effective and efficient generic drug review and GDUFA implementation
- Must possess a terminal degree in Medicine, Ph.D. in relevant field of pharmacology or systems pharmacology, or PharmD.
- Must possess a permanent, full, and unrestricted license to practice medicine (if applicant possesses an M.D.)to qualify.
- Extensive experience and knowledge of drug development and user fee implementation, including generics
- In-depth knowledge of the regulatory processes involving human drugs, including generics
- Strong leader with strategic vision and the ability to think analytically
- Significant experience with management, outreach, and communication
- Strong interpersonal skills and ability to effectively work across lines of authority and with various stakeholders of competing interests