Associate Director for Medicine (Chief Medical Officer)

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 6, Band G. . PRINCIPALES MISSIONS : Evaluates CBER medical program needs and capabilities; identifies improvement opportunities and executes strategic change through subordinate leadership to achieve organizational and public health goals. Oversees Center medical business operations including regulatory project management, resource capacity planning, hiring, and talent acquisition and development. Evaluates annual and ad-hoc budget requests from subordinate offices; makes funding recommendations based on trade-off analysis and alignment with Center priorities. Ensures user fee commitments are met with CBER/FDA partners; builds and maintains relationships with external and internal stakeholders to advance CBER's mission and goals. Advises the Center Director, Deputy Director, and senior FDA officials on medical activities affecting Center-wide programs, policy development, long-range goals, and public health priorities. Resolves controversies on biological products; makes hazard and risk classification determinations for product problems and recalls; develops policy and negotiates with other agencies on biologics approval criteria. Oversees quality of medical review processes Center-wide; reviews prior decisions for consistency; provides coordinative leadership to key officials and program managers. Develops clinical guidelines for biologicals related to INDs, BLAs, IDEs, and PMAs; provides authoritative medical risk assessments of compliance problems and adverse reaction data. Identifies weaknesses in Center medical programs; advises Director or takes corrective action; analyzes ongoing activities to eliminate duplication and optimize resources across federal and other agencies. Establishes and coordinates policy and program objectives for CBER medical programs aligned with Center, Agency, and government goals; keeps Center leadership informed on programs, resources, and planning. Represents the Center Director in meetings with departmental officials, industry, Congress, scientific organizations, and foreign officials to resolve complex medical/scientific issues and present FDA's position on biologics. Provides expert consultation to FDA's Office of the Commissioner, other Centers, government agencies, and international organizations; represents FDA at professional meetings and prepares Congressional testimony. Performs other duties as assigned. QUALIFICATIONS REQUISES : In order to qualify for the Associate Director for Medicine (Chief Medical Officer) position which falls under the 0602 occupational Series, you must meet the following requirements by 11:59 pm EST on 11/27/2026: The candidate must meet the following qualifications for this Title 21 position: Scientific, Technical, and/or Professional Fields Qualified and Outstanding Candidates a. Qualified applies to all candidates for Cures appointments. The FDA OTWS will use the technical qualifications defined below as a baseline for comparing experience levels and other candidate attributes for relevant positions b, Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both. To meet the Basic Qualifications for the Associate Director for Medicine (Chief Medical Officer) AD-0602, Band G position, you must possess the education requirement below. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. Technical Qualifications (Applicants do not need to submit a narrative

Salaire : $235,000 – $340,795/Per Year

Become a part of the Department that touches the lives of every American. At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. The position is located in the Department of Health and Human Serv