Associate Director for Medicine (Chief Medical Officer)

Duties
Summary
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. .
Requirements
Qualifications
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.
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 Services (DHHS), Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), in the Office of the Center Director, in Silver Spring, MD. This position is designated as an SES Equivalent position and is covered under the FDA Title 21 Executive Performance Management System and identified as a public filing position for ethics purposes.