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Office Director, Office of Surveillance and Epidemiology

Food and Drug Administration · Posted 63 days ago

Hybrid Silver Spring, MD $213K – $341K Apply by Aug 13, 2026 General Health Science INTJINTPISFJISTJ
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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, Band G.

What You'll Do

  • Directs budget planning, resource allocation, and fiscal oversight for office programs.
  • Reviews funding and staffing needs, recommends budget actions, and ensures efficient, cost-effective operations aligned with organizational priorities.
  • Serves as senior advisor on epidemiology, drug safety, and population health.
  • Develops policy, resolves complex issues, and advises FDA leadership and external partners on regulatory and public health matters.
  • Directs analysis and implementation of new laws, regulations, and policies affecting office programs.
  • Recommends organizational and operational changes to strengthen the Office's mission and regulatory effectiveness.
  • Leads high-priority drug safety initiatives and special projects that advance postmarket surveillance, regulatory science, and public health objectives.
  • Oversees postmarket drug safety programs and multidisciplinary staff conducting safety analyses using FAERS and other data sources to identify, assess, and address safety concerns.
  • Provides executive leadership for FAERS enhancements and electronic reporting.
  • Advises on regulatory issues, supports compliance activities, and represents OSE on key pharmacovigilance and labeling workgroups.
  • Reviews epidemiologic study designs, protocols, reports, and datasets submitted by industry to ensure scientific rigor and support evaluation of postmarket drug safety.
  • Oversees review of adverse event reports and collaborates with CDER offices to evaluate marketed drug safety and recommend appropriate regulatory actions.
  • Partners with OSE leadership to develop strategic plans, allocate resources, and guide decisions affecting office programs, priorities, and operations.
  • Represents OSE with Congress, federal agencies, industry, professional organizations, and other stakeholders.

Requirements

  • Ethics Clearance Requirements This position requires financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation.
  • If you are hired, you may be required to divest of certain financial interests.
  • You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.
  • For more information, please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
  • Education Requirements: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the position.
  • This degree must be from an educational program from an accrediting body recognized by the U.S.
  • Department of Education(external link) at the time the degree was obtained. https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0600/general-medical-and-healthcare-series-0601/ Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required.
  • Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.
  • TRANSCRIPTS (Required): Positions which are scientific or technical in nature often have very specific educational requirements.
  • You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.
  • Education must be accredited by an accrediting institution recognized by the U.S.
  • Department of Education in order for it to be credited towards qualifications.
  • Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S.
  • Department of Education.

Personality Fit

This role is commonly a great fit for these MBTI types:

Job ID: 4c5a5a3c-e8d6-48a5-a95e-1c99f7479d73

Posted via USAJobs

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