Version: 11/2021

Title 21 Vacancy Announcement 

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition (CFSAN)

Office of Nutrition and Food Labeling (ONFL)

Infant Formula and Medical Foods Staff (IFMFS)

Staff Director (Supervisory Physician) 

Application Period: December 21, 2023 – January 22, 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.

Position: Staff Director, Supervisory Physician for 

Infant Formula and Medical Foods Staff

Series: AD-0602, Physician 

Location(s): College Park, MD 

Work Schedule: Full Time

Salary: Starting at $195,000

Cures Band(s): Band E Full Performance Band Level: Band E

Travel Requirements: Up to 25%

Bargaining Unit: 8888, Non-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 safe, and effective.
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CFSAN is responsible for promoting and protecting the public's health by ensuring that the 

nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic 

products are safe and properly labeled.

Duties/Responsibilities

Infant Formula and Medical Foods provides technical knowledge and expertise in composition, 

nutrition, and safety of infant formulas set forth under the Infant Formula Act of 1980, and 

subsequent amendments. Manages and provides scientific review and analysis of infant 

formula submissions, petition dossiers, and inspection records as they are submitted in order to 

determine if the requirements for safety and nutritional adequacy have been met. Develops 

regulations, compliance policy, position papers, regulatory guidelines, guidance, and advisory 

opinions for matters within the scope of infant formula and medical foods. Provides expert 

advice to the Office Director, Center Director, other key officials and national and international 

bodies on infant nutrition and infant formula and medical foods initiatives and issues. Provides 

clinical and scientific expertise on the design and conduct of clinical trials for stakeholders, risk 

assessment, and adverse event reports. Provides training for and feedback to FDA Field 

investigators in order to strengthen FDA’s oversight on issues related to infant formula and 

medical foods. 

The incumbent serves as a Supervisory Physician in the Infant Formula and Medical Foods Staff 

of the Office of Nutrition and Food Labeling and is responsible for the following duties: 

• Identifies, researches, anticipates developments and recommends action(s) that will 

have a direct impact on the regulatory programs and policy for infant formula and 

medical foods. Recommends FDA actions that can involve drafting of proposed 

regulations, strategy documents, policy statements, formal guidance, letters to 

regulated industry, or various combinations of these actions within the context of 

applicable laws, policies, and regulations. Reviews final proposals for new regulations, 

policy statements and guidance involving infant formula and medical foods. Provides 

expert advice and guidance to scientific leadership on infant nutrition and medical foods 

within FDA, for other government agencies, the regulated industry, academia, and 

international regulatory scientific organizations.

• Recommends FDA actions that can involve drafting of proposed regulations, strategy 

documents, policy statements, formal guidance, letters to regulated industry, or various 

combinations of these actions within the context of applicable laws, policies, and 

regulations. Provides leadership and technical assistance on legislation and feedback for 

international regulatory authorities. 

• As a nationally and internationally recognized expert on infant formula, provides 

authoritative guidance on FDA positions and actions. Breaks new ground regarding FDA 

policies and procedures for industry, senior leadership, national and international 

organizations. 

• Supervises a staff of nutritionists, chemists, consumer safety officers and other staff 

with technical training in the area of infant formula and medical foods.
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• Develops, validates, and documents regulatory approaches to support the safe use of 

complex, novel ingredients in infant formula; provides leadership, including up-to-date 

knowledge regarding those ingredients that are bioactive. Where appropriate, the 

incumbent identifies areas of new science and proposes policy approaches and changes 

to address uncertainty or potential issues in novel safety assessments. Possesses the 

necessary leadership skills to develop standards of adequacy for the clinical and preclinical studies necessary to demonstrate that the quality factor requirements have 

been met. 

• Integrates nutrition science into developing policies, including internal guidance and 

standards, for the evaluation of infant formula safety and nutritional adequacy and for 

medical foods consults and queries.

• Works with FDA biologists, chemists, toxicologists, consumer safety officers and other 

technical staff to provide updates on complex scientific and regulatory matters arising 

from controversial topics in infant nutrition. Provides FDA leadership and oversight as a 

supervisor in the management and review of the most highly complex submission 

materials for infant formulas and controversial queries for infant nutrition and medical 

foods. The highest level of skill is involved in reviewing novel infant formula ingredients 

and procedures, for scientific validity of data. Reviews novel FDA infant formula and 

nutrition proposals to ensure consistency in approach and application of infant stagespecific regulation and policy across centers. Reviews FDA infant formula and nutrition 

assessments to ensure consistency in approach and application of infant stage-specific 

regulation and policy across centers.

• Makes formal national and international presentations on the FDA’s policies regarding 

infant formula review. Such presentations might include a discussion of current 

approaches to safety assessment, the type and amount of data needed to support the 

safety of infant formula products, and optimization of study protocols to assess the 

safety of food ingredients and constituents for infant developmental life stages.

Supervisory responsibilities: Supervises the Infant Formula and Medical Foods Team which 

includes nutritionists, chemists, consumer safety officers and other specially trained staff. 

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 equal 

opportunity in all Federal human capital and employment programs regardless of race, color, 

gender, national origin, religion, age, disability, genetic information, sexual orientation, 

affiliation or non-affiliation with a labor organization, political affiliation, status as a parent or 

gender identity. Provides employees resources and information that insures a safe and healthy

work environment.
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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:

Education: A degree from an accredited program or institution in Doctor of Medicine, Doctor of 

Osteopathic Medicine, or equivalent. Degree from Foreign Medical School: A Doctor of 

Medicine or equivalent degree from a foreign medical school must provide education and 
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medical knowledge equivalent to accredited schools in the United States. Evidence of 

equivalency to accredited schools in the United States is demonstrated by permanent 

certification by the Educational Commission for Foreign Medical Graduates.

AND

Graduate Training: 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. 

Desired Education: Our ideal candidate would have advanced training and board certification in 

neonatology or pediatrics.

Desired Professional Experience: 

• Highest level experience communicating complex technical information in a clear way 

and works with staff at all levels of the organization and varying levels of domain 

expertise; excellent listening skills and a commitment to communicate in a very timely 

manner. 

• Demonstrated ability in supervising and managing a team with specialized training.

• High level experience working independently, initiates own work, and also as a 

contributing, collaborative team member.

• Superior time management and organizational skills to effectively determine priorities 

and move work forward. 

• Demonstrated superior ability to develop networks and build alliances; collaborates 

effectively across boundaries to build strategic relationships and achieve common goals.

• Readily identifies internal and external politics that impact the work of the organization. 

Perceives organizational and political reality and acts accordingly.

• Identifies and analyze problems; weighs relevance and accuracy of information; 

generates and evaluates alternative solution; develops key policy and regulatory 

recommendations.

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 
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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: 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. 

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 

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

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.
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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

Submit resume or curriculum vitae, cover letter, and copy of all college transcripts and/or 

foreign education evaluation by the closing date as identified above to CFSANCURES@fda.hhs.gov and include the job reference ID: ONFL Staff Director, IFMFS. Candidate 

resumes may be shared with hiring official within the CFSAN with a similar job vacancy. 

Candidates can opt out of this process by annotating resume with “do not share”. For 

questions, please contact CFSAN-CURES@fda.hhs.gov and include the job reference ID: ONFL 

Staff Director, IFMFS. 

Announcement Contact

For questions regarding this Cures position, please contact CFSAN-CURES@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.