Description

Summary: 

The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Immunology and Inflammation (OII), Division of Hepatology and Nutrition (DHN). This position is being filled under a streamlined hiring authority, 21 US Code 379d-3a, as amended by the 21st Century Cures Act of 2016, § 3072 and the Consolidated Appropriations Act of 2023, § 3624.

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.

Overview

Opening & Closing Dates: 3/18/2026-4/17/2026

Salary: Table 3 Band C 

Pay Scale & Grade:  AD-602, Band C

Location: Silver Spring, MD

Remote Job:  Negotiable 

Telework Eligible: Yes

Travel Required: Less than 10%

Relocation Expenses Reimbursed:  Negotiable 

Application Period:  03/18/2026-04/17/2026

 
Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.

 
Position:  Medical Officer 
Series: AD-0602

 
Location(s):  Silver Spring, MD

Work Schedule:  Full Time 

 
Salary: Starting at Table 3, Band C, 

 
Title 21 Pay Table & Band: Pay Table 3 & Band C
Full Performance Band Level: Band C

 
Travel Requirements: No

Bargaining Unit: 8888

Relocation Expenses Reimbursement: Negotiable
 

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.

Additional information on 21st Century Cures Act can be found here:

21st Century Cures Act Information

Introduction
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.

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. 

21st Century Cures Act Eligibility: This position supports the development, review, or regulation of medical products and is funded 51% or more by Medical Product User fees. 

Duties/Responsibilities
 Determines whether clinical trials of new drugs in humans related to a focused therapeutic or diagnostic area are soundly conceived, and supported by prior animal testing and other controls adequate to justify tests in humans. Serves as an expert and resource for other clinical reviewers in a therapeutic or diagnostic area, in the comprehensive analysis and interpretation of safety and efficacy information in a submission, or regulatory or policy matters, including in crafting thorough and thoughtful benefit/risk assessments, and recommendations reflecting a deep understanding of the statutory and regulatory framework for regulatory decision-making.

Provides data-driven scientific assessments and conclusions on the efficacy and safety findings in review supplements and amendments to previously approved NDAs or BLAs; reviews periodic reports submitted by sponsors on drugs approved for marketing; reviews adverse reaction and other safety reports. Makes a clinical decision in each case as to whether the indicated population of a previously approved NDA or BLA should be expanded, whether changes in the labeling reflecting new safety information is required, and whether the information submitted and otherwise available, supports approval of the supplement.

Decisions are considered technically and scientifically authoritative and often forms the basis for the organization’s regulatory action. Reviews the summaries of pharmacologists and chemists as part of the decision-making process and determines whether or not to allow a study to proceed or to approve an application. Makes science-based recommendations that an NDA, BLA or a supplement submission be approved, with appropriate drug labeling for its safe and effective use. Makes science-based recommendations on protocols and amendments to an IND, including whether an IND is safe to proceed, requires modification, or should be placed on clinical hold. Provides authoritative comments on research designs and new endpoints or clinical procedures and, in meetings with industry sponsors of an application. Prepares correspondence (e.g., information requests) requesting additional data to provide clarity or address application deficiencies.

Requirements

Conditions of Employment
        U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.

        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.

        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.

        One year supervisory probationary period may be required. 

        Financial Disclosure may be required.

        Ethics Clearance may be required. 

        Background Investigation/Security Clearance is required. All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time. 

Qualifications
To be placed into a Cures position, candidates must meet the following criteria:

1.      Scientific, Technical, and Professional Fields

2.      Qualified and Outstanding Candidates

a.      Qualified applies to all candidates for Cures appointments. The FDA 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 Cures 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: 

Physician Series – AD-0602

A degree from an accredited program or institution in Doctor of Medicine, Doctor of Osteopathic Medicine, or equivalent. 

 In addition to a degree, a candidate must have had at least one year of supervised experience providing direct service in a clinical setting. For purposes of this standard, graduate training programs include only those internship, residency, and

fellowship programs that are approved by accrediting bodies recognized within the United

States or Canada. For more information please see: OPM Occupational Series

Qualification Requirements

 Desired Professional Experience: 

        Skill in applying their clinical and scientific expertise to complex multifaceted medical problems such as in benefit / risk determinations.

        Understanding of advanced scientific investigational principles, concepts, standards, and methods of research sufficient to test hypotheses conceived and able to apply findings from scientific research to support decision-making and make other appropriate actions

        Ability to resolve unique or novel problems and conditions, thereby addressing complex and challenging problems in the context of regulatory review of medical products.

        Knowledge of clinical, medical, and scientific literature and current clinical activities relating to new drugs and biologics in the assigned therapeutic area.

Education Transcripts
SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. 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 FDA employee, you are not exempt from transcript requirements.

 FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university.For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

Security Clearance Requirements
Background Investigation/Security Clearance Requirements:.

This position requires a security clearance and the incumbent has access to documents and facilities related to national security. Drug usage could impair the reliability, stability, and judgment of the incumbent which could undermine public confidence in the agency. Drug dependency would create the possibility of coercion and irresponsible actions leading to the disclosure of highly sensitive information. Therefore, this is a Testing Designated Position, and the incumbent is subject to testing for drug usage in accordance with the HHS plan for a Drug Free Workplace.

Ethics Clearance Requirements
This position may require 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. 

 Equal Employment Opportunity 
Equal Employment Opportunity Policy

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

Equal Employment Opportunity (EEO) for federal employees & job applicants

Reasonable Accommodation
Reasonable Accommodation Policy

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace. An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about disability employment and reasonable accommodations or how to contact an agency.

E-Verify
The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.

How to Apply
How to Apply: Submit resume or curriculum vitae with cover letter by 03/24/2026 to: OO-Talent-Coordination-Staff-Division-I-Actions@fda.hhs.gov.  Candidate resumes may be shared with hiring official within the CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. 

 For questions please contact Amy Harmon at OO-Talent-Coordination-Staff-Division-I-Actions@fda.hhs.gov.  Please reference Job Reference ID:  26-CDER-OII-DHN-0001.

Announcement Contact
For questions regarding this Cures position, please contact Amy Harmon , at  OO-Talent-Coordination-Staff-Division-I-Actions@fda.hhs.gov.

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.