Deputy Center Director

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 4, BandH.

Responsibilities

• Participates fully with the Center Director in planning, managing, organizing, and directing all operations, programs segments, functions, and activities of the Center.
• Serves as the Acting Center Director in the absence of the Center Director.
• 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.
• Learns legislative issues, representing the Center with Congress and stakeholders, guiding positions on legislation, and developing implementation plans following enactment of new laws.

Requirements

• U.S. Citizenship or proof of being a U.S. National is required by the closing date.
• The candidate must serve under a career or career-conditional appointment within the competitive service.
• All new hires must complete the I-9 form; this information will be processed through e-Verify to determine employment eligibility.
• Males born after December 31, 1959, must be registered with the Selective Service.
• All employees must pass a security investigation. Failing to pass the background check may be grounds for non-consideration, non-selection, or appropriate legal action.
• Applicants must submit all relevant transcripts that demonstrate they possess the required education to meet the Basic Qualifications.
• 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.
• The incumbent 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.
• The incumbent provides reasonable accommodations needed to best utilize qualified people with disabilities.
• The incumbent leads in an organizational management capacity, manages programs, resources, personnel performance, and human capital.

Qualifications

• Scientific, Technical, and/or Professional Fields: Qualified and Outstanding Candidates
• 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.
• 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.