Area of Consideration: Government-Wide United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective. The Center for Biologics Evaluation and Research (CBER) is a Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

The Office of Management leads procedural and process changes through developing and applying new strategies to emerging problems and new management initiatives, allocating dollars and staff resources to CBER’s program offices, monitoring their usage, and setting priorities to improve the level of customer service and program performance to meet CBER’s goal of protecting and promoting the public health. OM directs and monitors human resources, budget, payroll, space issues, assistance on human resources, provides administrative and technical support for advisory committee meetings, as well as provides laboratory and equipment support. In supporting the mission of the agency, OM develops, maintains, and supports a high quality and diverse workforce.

Duties/Responsibilities

The incumbent serves as the Branch Chief of the Planning, Performance, and Formulation Branch (PPFB) within the Division of Management Planning and Analysis (DMPA) and manages the daily operations of the Branch. This position reports to the Director of DMPA. PPFB monitors the development and operation of planning systems for Center activities and resource allocations including budget formulation, and advises the Center Director on Center administrative policies and guidelines; directs and counsels Center Senior Management through program evaluation, planning and forecasting; plans Center operations for financial, personnel, and facilities management and Office services; directs Center organization and management programs; and manages studies designed to improve processes and resource allocations in the Center. Specifically, the Branch Chief will: ➢ Provide comprehensive management of the operational activities within PPFB which include budget formulation, programmatic performance measurement, strategic planning, and executive-level performance management. ➢ Direct work to ensure that key national and organizational goals, priorities, values, and other issues are considered in making program decisions. ➢ Exercise leadership to implement and to ensure that the Center and Agency mission and strategic vision are reflected in the management of its people. ➢ Identify and integrate key issues affecting the organization including political, technological, and administrative factors. ➢ Understand the roles and relationships of the components of the national policy making and implementation process, including the President, political appointees, Congress, the judiciary, and relevant interest groups. ➢ Formulate and develop CBER budget requests and submissions to the Department of Health and Human Services (HHS), FDA, the Office of Management and Budget (OMB), and Congress. ➢ Facilitate effective engagement with stakeholders in the congressional appropriations process. ➢ Direct all strategic planning and performance measurement activities for CBER. ➢ Oversee the executive performance management process for SES and SES-equivalent executives within the organization. ➢ Exercise leadership and motivate managers to incorporate vision, strategic planning, and elements of quality management into the full range of CBER's activities. ➢ Establish program/policy goals and the structure and processes necessary to implement the organization's mission and strategic vision. Inherent in the process is ensuring that programs and policies are being implemented and adjusted as necessary, that the appropriate results are being achieved, and that a process for continually examining the quality of program activities is in place. Supervisory Responsibilities: Organizational Management: Manages a Branch. Program Management: Runs a program of singular discipline focus in the Center. Oversees or coordinates multiple functional activities. Resource Management: Monitors and reports on resources needed to run a Branch in the Center. Personnel Performance Management: Counsels and rates immediate subordinates. Human Capital Management: Identifies employee competency gaps.

Qualifications To be placed into a Cures position, candidates must meet the following criteria: 1. Scientific, Technical, and Professional Fields 2. Qualified and Outstanding Candidates a. Qualified applies to all candidates for Cures appointments.

The FDA OTS will use the basic requirements defined in the OPM Qualification Standards 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. In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications.

Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

Education Requirement: Candidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position. Please use the following link to determine the series for which you qualify: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualificationstandards/#url=List-by-Occupational-Series.

Desired Professional Experience, Skills, or Education: ➢ Leadership coaching, training, or certification. ➢ Prior management and/or operations experience with the federal government. ➢ Expertise in budget formulation, congressional/legislative affairs, strategic planning, and/or performance management. ➢ Ability to build and work effectively within teams. ➢ Ability to work collaboratively with diverse staff and stakeholders. ➢ Ability to prioritize and make critical decisions.

How to Apply

Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), SF50 (if applicable), latest signed PMAP (if applicable), a copy of your unofficial transcripts (if applicable), and letter of interest with “CURES CBER/OM/DMPA/PPFB Branch Chief” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through May 7, 2024.