Version: 11/2021

Title 21 Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Biologics Evaluation and Research (CBER)

Office of Therapeutic Products (OTP)

Application Period: Open continuously; applications will be reviewed periodically.

Area of Consideration: The Public

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: Physician*

*Multiple selections can be made across OTP 

Series: 0602 (Physician) 

Location(s): White Oak Campus, Silver Spring, MD. 241450031

Telework Eligible: Yes- as determined by the agency policy

Work Schedule: Full Time 

Salary: Starting at $165,000 and is set to 

commensurate with education and experience. 

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

Travel Requirements: Up to 25% Bargaining Unit: 3591

Note: Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain 

incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 

years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include 

the following: moving expenses, recruitment, or relocation incentive; student loan repayment, superior 

qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior 

uniformed military service, etc.

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 Center for Biologics Evaluation and Research (CBER) is a Center within FDA that regulates biological products 

for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, 

and Cosmetic Act. CBER’s mission is to protect and enhance the public health through the regulation of biological 

and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER protects 

and advances the public health by ensuring that biological products are safe, effective, and available to those who 
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need them. CBER also provides the public with information to promote the safe and appropriate use of biological 

products.

Duties/Responsibilities

The incumbent serves as a Physician within the Office of Therapeutic Products (OTP). The Office of Therapeutic 

Products (OTP) is a newly established Super Office within CBER which is responsible for the continued safety, 

purity, potency, and effectiveness of cellular, tissue, and gene therapies, plasma protein therapeutics, and other 

products regulated by OTP. The Physician will serve as a clinical reviewer who is a reviewer and advisor to OTP and 

other Center senior staff for the evaluation of the safety and effectiveness of novel biologic cell and gene 

therapies, plasma derived protein therapeutics, certain medical devices, and other OTP regulated medical 

products. 

Specifically, the Physician will: 

 Perform the regulatory review of a variety of regulatory submissions across the product development 

cycle to include but not limited to Pre-INDs, INDs, IDEs, BLAs and their amendments and supplements, 

and PMAs, and 510(k)s.

 Review the available literature and through their experience and knowledge, evaluate the proposed 

trial(s) to determine the risks and its potential benefits, and reviews the design of the protocol(s) for its 

ability to test the clinical hypothesis established for the study and to generate data that will be useful in 

the determination of its safety and effectiveness.

 Provide advice and make recommendations to sponsors on such matters as, the design of clinical studies 

for OTP regulated products such as cellular and gene therapy products and plasma protein derived 

products, both verbally and in writing. 

 Analyze and determine the adequacy of clinical trial data submitted by the sponsor/applicants to support 

the safety and efficacy of cellular and gene therapy products, plasma protein derived products, and other 

OTP regulated products.

 Recommend guidance to sponsors regarding all phases of clinical development and develops draft clinical 

guidelines and procedures, Federal register statements, and special projects. 

 Determine the appropriateness of the design with respect to the objectives of the study and the 

development of the drugs or devices; assures that reviews are completed on time, that potential benefits 

are weighed against reasonable foreseeable risks to human subjects, and that proposals are developed; 

and provides guidance to sponsors in answering questions central to drug development in a timely and 

safe manner.

 Evaluate the safety and adequacy of routine clinical development of cellular and gene therapy products 

from the first administration in humans through large, definitive trials intended to establish safety and 

effectiveness.

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.

• Financial Disclosure may be required.

• Ethics Clearance may be required. 
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• 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:

Candidates must possess the required individual occupational requirements to qualify for the appropriate series 

applicable to the position. The 0602 (Physician) series require a degree from an accredited program or institution 

in Doctor of Medicine, Doctor of Osteopathic Medicine, or equivalent. In additional to a degree, candidates 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, Experience, or Skills:

 An ideal candidate would possess an active medical license in at least one state or U.S. federal jurisdiction.

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

 Experience in clinical trial design, analysis, and/or regulation is desirable 

 Expertise in one of the following fields is desirable: 

o Internal Medicine or Pediatrics or any of the Internal Medicine or Pediatric subspecialties to 

include but not limited to: Hematology, Oncology, Endocrinology, Gastroenterology, Nephrology, 

Infectious Disease, Allergy/Immunology, Pulmonary, Cardiology, Rheumatology, Neonatology, 

Medical Genetics 

o Neurology, Ophthalmology, Dermatology 

o General Surgery, Orthopedics, Family Practice, Sports Medicine, Physician Medicine and 

Rehabilitation 

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. 
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Security Clearance Requirements

Background Investigation/Security Clearance Requirements: 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. 

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.

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

Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using 

month and year training completed, in addition to describing duties performed during that time period), SF50 (if 

applicable), latest PMAP (if applicable), unofficial transcripts, and letter of interest with “CURES CBER/OTP 

Physician” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be reviewed periodically. 

Announcement Contact

For questions regarding this Cures position, please contact CBERHumanCapital@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.