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.

FDA’s Chief Scientist provides strategic leadership, coordination, and expertise on scientific matters in order to support scientific excellence, innovation and capacity to achieve FDA's public health mission. Incumbent serves as the Chief Scientist and is responsible for facilitating coordination between multiple, smaller program offices; oversight of research; approval and disapproval of subject matter expert (SME) designation; and oversight for the activities related to policy, guidance, and process improvement development within the super office to enhance efficiency and ensure expeditious communication of decisions/actions across the Office, Agency and other external stakeholders, as appropriate. This position is located in the Office of the Office of the Commissioner, Office of the Chief Scientist.

Duties/Responsibilities:

• Provides executive and scientific leadership for FDA’s cross-cutting scientific research and related policies, programs, and initiatives;

• Participates a senior science advisor to the Commissioner on FDA science, innovation, and capacity in research to meet FDA’s regulatory mission and public health needs;

• As designated by the Commissioner, represents the Agency in meetings and conferences with officials/representatives of higher departmental echelons, counterpart government departments and agencies, national and international organizations and groups, the scientific and academic communities, and other stakeholders concerning the Agency scientific programs and activities. The incumbent is authorized to speak for the Commissioner and advocate for his/her and the Administration's priorities and initiatives.

• Facilitates scientific communication and cooperation at all levels, including among Centers and Offices, and nurtures interaction with the external scientific community to ensure the optimal use of available resources and tools to advance FDA’s mission;

• Supports the Centers in creating nimble, responsive, high quality scientific research organizations that consistently bring the best science to bear on FDA decision- making;

• Provides oversight of the development and implementation of strategies, plans, policies, and budgets to build and improve FDA’s regulatory and scientific capacities, systems, and programs, including:

• Developing the FDA Science and Research Plan for determining, prioritizing, and accomplishing the research needs of FDA;

• Developing and advocating for a budget to support intramural research;

• Tracking and, as appropriate, coordinating intramural research awards made by each center or science- based office within the Office of the Commissioner;

• Providing executive and scientific leadership in the development of agency fellowship programs;

• Facilitating and supporting training and skills improvement of the existing scientific workforce at FDA;

• Building capacity and expertise in the quantitative disciplines (e.g., data science, biostatistics, informatics) and other scientific disciplines across FDA;

• Developing and managing cross-cutting workgroups and develops cross-cutting extramural programs to advance FDA’s science agenda and knowledge base; and

• Facilitating and supporting efforts for the modernization of cosmetics implementation

• Ensuring that there is no duplication of research efforts supported by the Reagan- Udall Foundation for the FDA;

Qualifications

To be placed into a Title 21 position, candidates must meet the following criteria:

1. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Title 21 appointments. The FDA Office of Talent Solutions (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 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:

General Medical and Healthcare Series, 0601

Candidates must have the following:

Degree - a doctoral-level degree from an accredited institution of higher learning, such as: Ph.D., M.D., D.V.M., D.D.S., D.N.D., Sc.D., or degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position equivalent to a Ph.D.;

AND

Professional Experience:

• A minimum of five years related experience in the scientific, clinical, and/or public health research fields.

• A strong record of peer-reviewed original and applied research.

• Strong interest in the breadth of science applicable to FDA regulatory programs.

• In-depth knowledge of the Agency’s policies, and scientific and regulatory programs as they relate to medical products.

• Talent for building partnerships and coalitions with stakeholders in public and private arenas.

Mandatory Managerial/Executive Qualifications:

Candidates must have the ability to bring about strategic change, both within and outside the organization, to meet organizational goals; the ability to lead people toward meeting the organization’s vision, mission, and goals:

• Ability to meet customer expectations;

• Ability to manage human, financial, and information resources strategically;

• Ability to build coalitions internally and with other Federal agencies, State and local governments, nonprofit and private sector organizations, foreign governments, or international organizations to achieve common goals.

Desired Qualifications:

Candidates should have:

• Executive level administrative or managerial experience that demonstrates sound judgment, strong leadership abilities in a scientific or public health environment;

• Demonstrate leadership competence and abilities to:

• develop complex and basic program goals, and assure that agency goals and priorities are considered in carrying out and completing responsibilities;

• direct and guide projects, including long-term and short-range planning;

• establish objectives and priorities;

• conduct periodic program assessments;

• plan and direct the work of a large scientific research staff;

• Experience indicating the ability to communicate and effectively interact with the scientific/academic and public health communities; medical and other health-related organizations; high level government officials, including members of Congress, principal representatives of counterpart Federal agencies, foreign government officials; CEO-level and other senior representatives from regulated industry; and other research stakeholders.

• Experience leading a significant scientific organization within government, industry, or academia;

• Extensive knowledge in the development and manufacturing of drugs, devices, biologics, food, veterinary products, cosmetics, and/or tobacco products;

How to Apply

How to Apply: Submit resume or curriculum vitae with cover letter by 11:59pm on 6/3/2024 to: CuresExecutives@fda.hhs.gov.

For questions, please contact CuresExecutives@fda.hhs.gov. Please reference Job Reference ID in subject line of email: OC-OCS-2024-02