Director, Office of Science and Engineering Laboratories (OSEL)

Food and Drug Administration • Silver Spring, MD

20h

About The Position

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. The Director provides executive leadership overseeing multidisciplinary programs in physical sciences, engineering, biological sciences, and computational science applied to the safety and effectiveness of medical devices and radiation-emitting products. The role involves setting scientific strategy for OSEL, aligning priorities with CDRH and FDA-wide goals, and anticipating emerging technologies and regulatory challenges. The Director will lead cutting-edge research programs to develop test methods, measurement frameworks, computational models, and scientific tools that underpin FDA's regulatory decisions. This position also advises senior leadership, including the CDRH Director, on significant scientific and engineering matters affecting medical device regulation, shapes regulatory science as a discipline by establishing novel frameworks and methodologies, and builds strategic partnerships with federal agencies, industry, standards organizations, international counterparts, and academia. The Director manages a highly skilled workforce spanning multiple laboratories and scientific disciplines.

Requirements

• 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.
• Males born after December 31, 1959, must be registered with the Selective Service.
• Background Investigation Requirement: All employees must pass a security investigation.
• 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.
• 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.
• Ethics Clearance and Financial Disclosure is required
• Degree: physical science, engineering, or mathematics that included 24 semester hours in physical science and/or related engineering science such as mechanics, dynamics, properties of materials, and electronics OR Combination of education and experience -- education equivalent to one of the majors shown in A above that included at least 24 semester hours in physical science and/or related engineering science, plus appropriate experience or additional education.
• Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
• Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.

Nice To Haves

• 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.

Responsibilities

• Provides executive leadership overseeing multidisciplinary programs in physical sciences, engineering, biological sciences, and computational science applied to the safety and effectiveness of medical devices and radiation-emitting products.
• Set scientific strategy for OSEL, aligning priorities with CDRH and FDA-wide goals and anticipating emerging technologies and regulatory challenges.
• Lead cutting-edge research programs that develop the test methods, measurement frameworks, computational models, and scientific tools that underpin FDA's regulatory decisions.
• Advise senior leadership, including the CDRH Director, on significant scientific and engineering matters affecting medical device regulation.
• Shape regulatory science as a discipline by establishing novel frameworks and methodologies adopted across FDA and by domestic and international regulatory partners.
• Build strategic partnerships with federal agencies, industry, standards organizations, international counterparts, and academia.
• Manage a highly skilled workforce spanning multiple laboratories and scientific disciplines.
• The incumbent is delegated full authority to achieve group goals and objectives through the effective management of available resources.
• Ensures financial and managerial accountability by acting with prudence when executing fiduciary responsibilities.
• 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.
• 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.
• 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.
• 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.
• Identifies employee competencies necessary to meet OSEL's organizational capabilities goals across its 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.

Benefits

• A career with the U.S. government provides employees with a comprehensive benefits package.
• As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding.
• Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent.
• moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree