Office Director, Office of Surveillance and Epidemiology
Duties 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.
Requirements
Qualifications: In order to qualify for the Office Director, Office of Surveillance and Epidemiology position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 08/13/2026:
The candidate must meet the following qualifications for this Title 21 position:
Scientific, Technical, and/or Professional Fields Qualified and Outstanding Candidates
a. 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
b. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.
Technical Qualifications: Candidates do not need to provide narrative responses. However, the technical qualifications must be reflected within the candidate's two-page resume.
At least 3 years experience in managing a multi-disciplinary professional staff that is responsible for developing and using epidemiologic and other evidence to assess the effectiveness and safety of human drug and therapeutic biologic products and making recommendations on actions to improve patient safety and protect and promote the public health.
Demonstrated ability in providing authoritative and professional expertise in health sciences, including epidemiology, drug safety and population health issues related to the regulation of human drug and therapeutic biological products to internal and external stakeholders.
Demonstrated ability in providing critical reviews in the study design and methods of epidemiologic and other study protocols relevant to the assessment of post-marketing drug safety submitted by the pharmaceutical industry.
Desired Qualifications: Experience applying the Food and Drug Administration Amendments Act, regulations, policies, and procedures related to the regulation and evaluation of drugs and biologic products.
Supervisory Responsibilities
The incumbent provides occupational specific technical and administrative direction 25 percent or more of the time to three or more subordinate employees performing the work and functions of the organization. Obtains resources and identifies strategic objectives for the organization. Defines jobs, selects employees, and assigns work; defines technical work requirements and milestones; evaluates the organization and employee accomplishments by accepting or rejecting work products; and presents and defends organization and employees work to senior management and other offices. Recommends employee promotions and recognition; approves leave; implements performance modifications and takes corrective actions as appropriate. Provides employees with resources and information that ensure a safe and healthy work environment.
Conditions of Employment
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. If a discrepancy arises, you must take affirmative steps to resolve the matter.
Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for non-consideration, non-selection, or appropriate legal action.
If hired, you may be subject to additional investigations at a later time.
Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
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.
Appointment to the position will be contingent upon a negative applicant drug test result.
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.
Pre-employment physical required: No
Mobility agreement required: No
Immunization required: No
Bargaining Unit: No
Telework eligible position: Telework is at the discretion of the supervisor.
Ethics preclearance/OGE-278, required: Please be advised that this position is subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests.
Financial disclosure statement, required: 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.
Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
Applicants must meet all qualification requirements by the closing date of this announcement.
About the Agency
The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), CDER, OSE, OPE. The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
About the Agency
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.