Director, Office of Science and Engineering Laboratories (OSEL)

FDA; Silver Spring (MD); On-site; USD 150,000 - 210,000; Full time

Job summary

The FDA, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories seeks a Director to lead multidisciplinary regulatory science programs across life sciences, engineering, and computation. You will shape strategic direction, manage budgets, and advance scientifically rigorous policies in service of public health.

Ideal candidates hold a Ph.D. in life sciences or an MD/PhD, with proven leadership in regulatory science, program management, and cross‑agency

Qualifications

• Senior-level qualifications in regulatory science leadership and program oversight.
• Experience leading multidisciplinary research and regulatory programs.
• Strong strategic planning and resource management for science programs.

Responsibilities

• Lead and manage a multidisciplinary regulatory science program across multiple laboratories.
• Direct strategic priorities aligning with FDA and agency-wide goals.
• Oversee resource planning, budgeting, and performance evaluations.
• Provide leadership to a diverse workforce, promoting collaboration and accountability.
• Ensure effective communication of program issues to external audiences.

Skills

Regulatory science leadership

Program management

Strategic planning

Cross-functional leadership

Regulatory compliance

Education

PhD in life sciences or MD/PhD

Job description

Summary

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 G.

Duties

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 G.

Qualifications

In order to qualify for the Director, Office of Science and Engineering Laboratories (OSEL) position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 10/28/2026: The candidate must meet the following qualifications for this Title 21 position: Scientific, Technical, and/or Professional Fields

• 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
• Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both

Minimum Qualifications: To qualify for a Band G Director, Office of Science and Engineering Laboratories (OSEL) position, you must meet the Education Requirement listed in the Education section below. Desired Qualifications: Possesses a Ph.D. in the life sciences or an M.D./Ph.D. degree, with advanced research and scientific training relevant to the position. The preferred qualification reflects the depth of research expertise needed to lead multidisciplinary regulatory science programs and address complex scientific and emerging technologies. An M.D. without a Ph.D. is not considered equivalent to the preferred research and scientific background. 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. While PHS Commissioned Corps Officers cannot hold a Title 21 position during their active service as PHS Officers, we welcome and encourage them to apply-their applications will receive full consideration. Please note that if selected, the Officer will need to end their Commissioned Corps appointment before being placed in the Title 21 position. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

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.

Organizational Management: Manages the Office of Science and Engineering Laboratories (OSEL) within CDRH to sustain and advance a preeminent regulatory science enterprise capable of addressing frontier scientific challenges at the forefront of medical device regulation. Establishes strategic direction and priorities across OSEL's scientific programs spanning life sciences, biological sciences, engineering, physical sciences, and computational sciences. Ensures alignment of OSEL's organizational objectives with CDRH and FDA-wide priorities and regulatory mission.

Program Management: Runs a multidisciplinary regulatory science program in the Center encompassing multiple laboratories and scientific disciplines. Directs and evaluates activities addressing scientific and technical questions relevant to medical devices and radiation-emitting products, including test methods, biocompatibility, biological testing, in vitro/in vivo evaluation, computational modeling, and reference materials. Establishes new scientific programs and frameworks in areas without precedent, shaping how emerging and complex technologies are evaluated across the regulatory enterprise. Oversees a highly diverse workforce across scientific, professional, technical, and administrative occupational series.

Resource Management: Monitors and reports on resources needed to lead strategic resource planning for OSEL and its multidisciplinary regulatory science programs. Establishes annual and multi-year objectives, determines program priorities, and allocates resources across OSEL's scientific programs. Evaluates the effectiveness and regulatory impact of OSEL programs to inform resource planning and ensure efficient use of available resources in support of CDRH's regulatory mission.

Human Capital Management: Identifies employee competencies necessary to meet OSEL's organizational capabilities goals across multidisciplinary scientific workforce. Designs competency frameworks and workforce architecture to ensure OSEL maintains the scientific capabilities needed for current and emerging regulatory science challenges. Promotes employee development and identifies workforce and succession needs to ensure OSEL maintains the scientific knowledge, methods, tools, and capabilities required to address current and emerging regulatory challenges. Provides leadership to subordinate managers and supervisors and ensures effective and equitable management of the organization. Provides reasonable accommodations needed to best utilize qualified people with disabilities.

Become a part of the Department that touches the lives of every American. At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL). The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.