Associate Director for Medicine (Chief Medical Officer)

About the role

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.

What you will do

• 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.

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: National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service.

For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above. This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy.

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test.

Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Documents you must provide

• At a minimum, your resume should list the position title, employer name, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed.
• A CV (curriculum vitae) may not contain enough information to meet these resume requirements.
• USAJobs - What to Include USAJobs - Page Limit Your two (2) page RESUME showing all relevant work experience (paid and unpaid) including: duties performed; full name and address of each employer; start and end dates (month/day/year); work schedule (part-time, full-time, number of hours if intermittent); salary; and any completed education and training (program title, subject area, number of hours completed, and completion date).
• Transcripts (Required): If the position has an education requirement or you are qualifying based on education, unofficial transcripts or a list of courses must be provided.
• See the Qualifications and Education Requirements section of this announcement.
• Additional Documents (if applicable): Cover Letter Other supporting documentation not listed above Resume Separation Notice (RIF) SF-50/ Notification of Personnel Action Transcript Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

What to expect next

Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. Your feedback matters. Please complete this brief survey and let us know how we are doing.

Additional information

Additional Conditions of Employment: Pre-employment physical required: No Drug testing required: Yes License required: No Mobility agreement required: No Immunization required: No Bargaining Unit: No Telework eligible position: Telework is at the discretion of the supervisor.

Financial disclosure statement, SF-278, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.

This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.

For more information please visit the FDA Ethics web page: *** Additional Information: Additional selections may be made for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. Incentives may be authorized; however, this is contingent upon funds availability.

If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid.

Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc. If you are serving, or have served in the last 5 years (from 11/27/2026) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment.

You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment.

In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more. Active-duty U.S. Public Health Service Commissioned Corps Officers are encouraged to apply.

If selected, officers may either (1) remain on active duty assigned to the designated billet for PHS assignment, or (2) separate or retire from the Commissioned Corps before entering a Title 21 civilian appointment. All requirements must be met by the closing date of this announcement (11/27/2026); only education and experience gained by this date will be considered.

You must continue to meet all requirements throughout the entire hiring process.