Associate Director for Medicine (Chief Medical Officer)

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, these qualifications must be evident within your two (2) page resume: Executive leadership experience including an established track record in biologics or drug development and in the management of organizations and budgets of significant size.

Effective written communication skills to develop policy, guidance to industry, internal procedures, and responses to Congressional inquiries, and to provide advice to CBER senior officials. Effective oral communication skills to exercise tact, diplomacy, and technical expertise to communicate Center/Agency policies related to the development of biological products.

Desired Qualifications: Mastery knowledge of the Federal Food, Drug, and Cosmetic Act; experimental design; theories and practices used in new biologics evaluation; and current clinical and research data and activities related to biological product development.

Mastery expert knowledge of FDA/CBER regulatory science and associated disciplines to allow the review of a variety of complex INDs, IDEs, BLAs, PMAs, 510(k)s, master files, supplements, and amendments from manufacturers of products intended for use nationally in the diagnosis, treatment, and prevention of specific diseases in humans.

Mastery professional skills in collaborating and facilitating with a variety of officials at various levels of authority from both public and private organizations, including senior management officials, Center-level officials, Office of the Commissioner, other FDA Centers, other federal agencies, Congress, the scientific/medical community, academia, and regulated industry.

Mastery of advanced medical theories, practices, and techniques as applied to biological product evaluation, typified by the completion of an approved medical residency program supplemented by clinical or research experience. Background Investigation/Security Clearance Requirements: Critical Sensitive/High Risk Drug Impact Statement for Top Secret Security Clearance: The position requires a Top-Secret security clearance, and the incumbent has access to documents and facilities related to national security.

In accordance with Executive Order 12564 of September 15, 1986, The Department of Health and Human Services (HHS) is A Drug-Free Federal Workplace. The Federal government, as the largest employer in the Nation, can and should show the way towards achieving drug-free workplaces through programs designed to offer drug users a helping hand, and at the same time demonstrating to drug users and potential drug users that drugs will not be tolerated in the Federal workplace. This is a Testing Designated Position.

Incumbent must submit to and successfully pass an urinalysis drug screening prior to appointment. The Incumbent will also be subject to unannounced random drug testing for the duration of their time in this position. The use of illegal drugs, on or off duty, by Federal employees is inconsistent not only with the law-abiding behavior expected of all citizens, but also with the special trust placed in such employees as servants of the public.

All applicants tentatively selected for this position will be required to submit to urinalysis to screen for illegal drug use prior to appointment and can be subject to random, reasonable suspicion, and post-accident drug testing upon hiring. Appointment to this non-bargaining unit position will be contingent upon a negative drug test result. Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring.

To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring.

Supervisory Responsibilities: The CMO plans and sets long-range plans and schedules for the work of the Center, assures implementation by supervisors, managers, and organizations throughout CBER, as well as within the Rare Disease Staff. This includes determining goals and objectives that need additional emphasis, determining the best approach and solutions for resolving budget problems, and planning for long-range staffing needs.

Exercises delegated authority to oversee the overall planning, directing, and execution of several program areas managed by subordinate office directors, division directors, first-line supervisors, and team leaders. Reports to the CBER Center Director. Provides reasonable accommodations needed to best utilize qualified people with disabilities.

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.