Deputy 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 H.

In order to qualify for the Deputy Center Director position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 03/25/2026: 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 organization.

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.

Leads in a proactive, customer-responsive manner consistent with Agency vision and values, effectively communicating program issues to external audiences.

Ensures financial and managerial accountability by acting with prudence when executing fiduciary responsibilities.

Demonstrates high integrity and adheres to the highest ethical standards of public service.

Uses effective business practices including balanced measures of results, values, and invests in each employee; emphasizes empowerment and two-way communication.

Takes a leadership role in advocating for and advancing the priorities of the Agency. Serves as a role model for leadership by encouraging teamwork and a collaborative approach.

Timely notifies Agency officials of all significant actions and developments, including but not limited to those related to regulatory matters, legislative matters, budget matters, reports, initiatives, and events and ensures subordinate managers do the same.

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.

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.

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 the Deputy Center Director, participates fully with the Center Director in planning, managing, organizing, and directing all operations, programs segments, functions, and activities of the Center.
• Represents the Center Director and serves as the Acting Center Director in his or her absence.
• Serves to organize and coordinate matters brought to the attention of the Office of the Center Director and acts as an advisor to the Center Director on issues requiring decisions based upon comprehensive reviews of the issues.
• Acts as a principal policy advisor to the Center Director on issues that require the most careful analysis concerning strategic initiatives and regulatory policy programs for CBER.
• Establishes and maintains effective Center-wide governance and clearance mechanisms for advancing policymaking within the CBER and in collaboration with other FDA Centers and Offices.
• Participates with the Office Directors in monitoring policy development and policy implementation activities of interest to the Center Director. Evaluates Center-wide ongoing biological product policies.
• Develops, prepares, and presents authoritative memoranda, briefings, position papers and other materials concerning substantive questions, issues, findings, conclusions and proposed solutions and suggested courses of action.
• Collaborates with the Center Director and Agency leaders to develop policy on pre-market product access and approvals, labeling, exclusivity and incentives, and emerging biological technologies and tools, including for cross-Center coordination.
• Directs special studies and workgroups on major issues, reviewing and evaluating Center programs and consulting with Agency officials to address problems with regional, national, and international impact, and recommending actions to resolve them.
• Provides authoritative guidance to leadership on short- and long-term activities to maximize CBER’s public health impact; reviews and analyzes program reports, proposals, memoranda, and other materials affecting Center operations.
• Shares responsibility with the Center Director to identify opportunities, develop strategies, and cross-Center projects. Oversees improvements in governance, hiring, and strategic planning while building strong coalitions.
• Leads the Center’s strategic engagement on legislative issues, representing the Center with Congress and stakeholders, guiding positions on legislation, and developing implementation plans following enactment of new laws.