Center Director

Full Job Description

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 4, Band I.

In order to qualify for the Center Director position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 04/03/2026: 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 OTS 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. Technical Qualifications: Candidates do not need to provide narrative responses.

However, the technical qualifications must be reflected within the candidate's two-page resume. Executive level experience directing a large organization.

Experience establishing organizational policy, including the implementation of new legislative authorities or other significant mandates.

Demonstrated ability to communicate effectively both internally and externally to a large number of staff located in different geographic areas.

Demonstrated ability and experience coordinating complex work and priorities and building coalitions with partners in other organizations.

Extensive experience and knowledge of the FDA's regulatory and review process; strong leadership and significant executive management experience.

Demonstrated knowledge and experience in the regulation and development of biological products, including the evaluation of safety, effectiveness, and product quality.

Desired Qualifications: Knowledge of Federal laws and regulations and DHHS and FDA policies and procedures. Talent for leading cultural and organizational change management efforts.

Knowledge and awareness of the Director's interests and objectives in all matters involving the application of regulatory and policy judgement.

Experience interacting with the media and with entities that perform oversight activities, such as Congress or the General Accountability Office or a Board of Directors.

An advanced degree in law, science or management from an accredited college or university.

Supervisory Responsibilities The incumbent is delegated full authority to achieve group goals and objectives through the effective management of available resources.

Performance and accomplishments are assessed primarily through work performance indicators, staff discussion, planning sessions, review of individual project outputs, and annual program review.

Provides administrative and technical supervision necessary for accomplishing the work of the Center.

Carried out through subordinate Office and Division supervisors and the skilled staff of professionals organized into subordinate organizations who are all responsible for achieving CBER's mission.

Provides reasonable accommodations needed to best utilize qualified people with disabilities.

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.

Public Health Service Commissioned Corps Officers interested in applying for this position to serve in Title 21 must resign their commission if selected.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. 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.

FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility.

If a discrepancy arises, you must take affirmative steps to resolve the matter. Males born after December 31, 1959, must be registered with the Selective Service.

Please go to http://www.sss.gov for more information. Background Investigation Requirement: All employees must pass a security investigation.

Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.

Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification.

False representation may be grounds for non-consideration, non-selection, or appropriate legal action.

All applicants tentatively selected for this position will be required to submit to urinalysis to screen for illegal drug use prior to appointment and be subject to random, reasonable suspicion, and post-accident drug testing upon hiring.

Appointment to the position will be contingent upon a negative applicant drug test result.

One-year probationary period is 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.

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.

Ethics preclearance/OGE-278, required: Please be advised that this position is 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.

For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

Financial disclosure statement, required: This position requires 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.

Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.

Applicants must meet all qualification requirements by the closing date of this announcement. Major Duties:

• As Director of the Center for Biologics Evaluation and Research, the incumbent leads the Center’s regulatory, scientific, and policy work overseeing biological products under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.
• Leads and manages the Center’s efforts to advance the development and approval of safe, effective biological products, including blood and blood products, vaccines, and cellular, tissue, and gene therapies.
• Leads post-approval oversight to ensure safety, effectiveness, and quality through inspections, testing, and surveillance; develops standards for global harmonization; conducts research; and collaborates on policy and user fee programs.
• Leads development, implementation, and management of national programs and policies to ensure the safety, effectiveness, and quality of biological products for human use.
• Advises the Commissioner and senior FDA officials on biological product matters affecting policy, execution, and long-term goals; provides counsel on industry positions, precedents, consumer protection, legislation, and regulatory implementation.
• Leads program goals, advances biologics development, enforces FDA standards, promotes compliance, and fosters cooperation to balance oversight with responsiveness to consumer needs.
• Evaluates Center activities, sets or recommends policy, and acts for the Commissioner in analyzing findings from program reports across the Center and Agency.
• Determines the need for major changes in Center policy and direction and short/long range program goals. Identifies significant weaknesses/problems in Center programs and advises the Commissioner or determines/ initiates/takes corrective action.
• Analyzes how Center programs support each other, identifies obstacles, and ensures efficient resource use while reducing duplication across federal, state, and local programs.
• Participates in setting national goals, shaping policies and programs for biologicals, evaluating program changes, and ensuring efficient use of Center resources to meet Agency objectives and interagency commitments.
• Represents the FDA Commissioner in meetings with officials, industry, Congress, and agencies; presents expert recommendations on biological products; and directs FDA resources to address issues and develop solutions.
• Testifies before Congress with FDA leaders and provides authoritative advice on biological products, policies, programs, regulations, legislation, and agency-wide matters to officials, staff, and intergovernmental partners.
• Leads staff overseeing biologics programs, ensuring safe development, post-approval quality, inspections, testing, surveillance, and international standards.