Associate Director for Medicine (Chief Medical Officer)

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 Table6, Band G.

Duties

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• 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.

Requirements

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Conditions of employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
• Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.
• Ethics Clearance and Financial Disclosure is required

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:

1. Scientific, Technical, and/or Professional Fields
2. 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:

1. Executive leadership experience including an established track record in biologics or drug development and in the management of organizations and budgets of significant size.
2. 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.
3. 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:

1. 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.
2. 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.
3. 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.
4. 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

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.

Education

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

TRANSCRIPTS (REQUIRED): Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.

Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

1. National Association of Credential