Version: 11/2021

Title 21 Vacancy Announcement – Physician

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Office of the Commissioner

Office of Clinical Policy and Programs

Office of Clinical Policy (OCLiP)

Application Period: January 2, 2024 – Feb 1, 2024

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.

Series: 602

Salary: Table 3: $180,000-$288,365

Full Performance Band Level: Band D

Position: Physician (Senior Medical Advisor & Bioethics

Consultant Ethicist)

Location(s): Remote

Work Schedule: Full Time

Cures Band(s):Band D

Travel Requirements: N/A

Bargaining Unit: Bargaining Unit

Relocation Expenses Reimbursement: You may qualify for reimbursement of relocation 

expenses in accordance with agency policy.

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 are safe and effective. 

This position is located in the Office of Clinical Policy (OCliP), within the Office of Clinical Policy 

and Programs, in the Office of the Commissioner. OCliP is the focal point within the FDA for 

human subject protection issues arising in clinical investigations regulated by FDA. Among other 
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things, the Office provides ethical expertise to help resolve scientific and regulatory issues 

involving adult human research subjects across all of FDA’s Centers. As a Senior Medical 

Bioethicist on the Adult Bioethics Team within OCliP, the incumbent provides independent

review of adult human subject research ethics issues and participates in the planning,

management, and implementation of bioethics activities across the FDA’s Centers. Activities will 

include human subject research ethics consultations, providing ethics training to interested 

parties within and outside the Agency, and policy development pertaining to a wide range of 

research ethics issues.

Duties/Responsibilities

Recognized as an agency medical expert in the protection of human subjects in clinical trials 

and research ethics. Spends the majority of their time providing expert consultative services 

to the Agency’s medical product review divisions on research ethics issues that arise during 

review of medical products intended for adult patients, including with respect to clinical trials 

that have a national or international impact on public health and public health policy. 

Analyzes clinical studies and performs critical reviews for sufficiency according to the 

Agency’s regulations on informed consent and human subject protections. Collaborates as a

recognized expert with other members of the Adult Bioethics Team as well as colleagues on 

the Pediatric Bioethics Team to advise on unique, far-reaching, and previously unresolved 

problems involving research ethics related to FDA-regulated clinical trials. Analyzes ethical

implications for research programs in areas that require extensive interpretation and provides 

authoritative guidance to Center leadership and staff. Helps to conceive and develop valid

approaches to complex bioethical issues that become Division, Center, or Agency policy and 

procedure. Maintains close personal contact with the “state of the science” and research 

ethics literature in order to inculcate the most advanced theories and practices in the field of 

bioethics into premarket review activities. Keeps fully abreast of crucial and precedent-setting 

cases related to bioethics both within the Adult and Pediatric Bioethics Teams and under 

review at the Agency. Has active work on the protection of human subjects from research 

risks through provision of consultation services in the design, review, and monitoring of 

research protocols. Serves as an expert bioethics advisor in meetings with Center Division 

staff and other Center and Agency officials, as well as with the regulated industry, on 

problems related to products under review. Uses clinical, scientific, and bioethics expertise, as

well as care and sensitivity, to resolve issues raised by biomedical research.

In collaboration with senior staff, serves as a resource for research ethics, provides review of 

research ethics issues across the FDA’s Centers, and participates in the planning, 

management, and implementation of bioethics activities across all of FDA’s Centers. 

Establishes and maintains communication within the Centers of the Agency to facilitate the

exchange of scientific and regulatory information on human subject protections and research 

ethics, and to ensure that policy issues are addressed appropriately.

Contributes to regulatory standards for the ethical evaluation of the safety, effectiveness, 
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and quality of regulated products. Personally explains critical and significant concepts of 

research ethics to internal and external parties. Briefs supervisor, office director and other 

relevant FDA executive leadership on relevant conclusions and interpretations related to 

ethical matters. Coordinates and provides interpretation and guidance on overall policy and 

special issues related to human subject protections and research ethics. As a leading Agency 

authority and expert in the regulatory field of human subject protection and research ethics, 

integrates knowledge and experience to resolve problems, modify procedures, and develop 

and interpret complex policies to meet new and novel conditions. Actions taken and 

solutions devised cut across other functional areas within the organization. Leads task forces 

and work groups charged with considering problems or directions in human research

protections. Leads or serves on committees charged with the review of federal policies and 

procedures related to human research protections that cross organization lines. Leads or 

serves as a member of task forces and working groups called to consider problems or 

direction in the field of research ethics and develop policy related to human subject 

protection. Delivers briefings on findings and recommendations.

As a recognized authority, expert, and leader in human subject protections and research

ethics, provides information and consultation to individuals both within and outside the 

Office, Agency, to include, as necessary, federal agencies, private industry, universities, 

and/or foreign governments. Possesses specialized skill that is recognized by agency officials, 

other federal agencies, state, local, and foreign governments, regulated industry, and/or 

professional trade and citizen organizations directly affected by the program. Counsels and 

trains team members and other FDA staff on Agency regulations and policy related to human 

subject protection. Develops and implements educational programs on contemporary issues 

in biomedical ethics, especially as they relate to the Agency’s mission in clinical research. 

Provides such training to external parties via attendance at professional meetings both within 

and outside the Federal government.

Prepares and gives presentations concerning the interpretation and analysis of regulations 

related to research ethics to state, local, and foreign governments, subject matter experts, 

upper levels of management, industry, and academia. Represents the organization before 

high-level national and international audiences regarding regulatory policies and programs 

related to research ethics. Defends Agency positions, interpretations, and policies related to 

research ethics before international organizations, government agencies, industry, 

academia, consumer organizations, and the scientific/medical community.

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 
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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.

• 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, 0602 Requirements: One-year probationary period may be 

required; Official transcripts required; Degree must have been accredited by the Council on 

Medical Education of the American Medical Association; Association of American Medical 

Colleges; Liaison Committee on Medical Education; Commission on Osteopathic College 

Accreditation of the American Osteopathic Association, or an accrediting body recognized by 

the U.S. Department of Education (external link) at the time the degree was obtained.

Desired Education: Ideal candidate will possess an M.D. and have completed additional formal 

education (e.g., a Masters degree in Bioethics) and/or certification in medical ethics or 

bioethics.

Desired Professional Experience: 

• Recognized as an expert and leader in medical ethics and/or bioethics, with demonstrable 
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experience addressing complex ethical issues in a clinical setting.

• Knowledge and experience regarding FDA scientific and review policies is desirable  

• Ability to independently evaluate medical and/or scientific research and/or evidence in 

a wide variety of disciplines for the purpose of addressing complex ethical issues. 

• Extensive collaboration, and communication skills to advise on complex and nuanced 

ethical issues and deliver a consensus approach. 

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. 

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 
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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 February 1, 2024 to: 

Jessica.Bennett@FDA.HHS.GOV. Candidate resumes may be shared with hiring official within 

OCPP with a similar job vacancy. Candidates can opt out of this process by annotating resume

with “do not share”.

Announcement Contact

For questions regarding this Cures position, please contact Jessica Bennett via email or 301-

796-3070.

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

free environment.

FDA is an equal opportunity employer.