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Title 21 Cures Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Biologics Evaluation and Research (CBER)

Office of Vaccines Review and Research (OVRR)

Division of Clinical and Toxicology Review (DCTR)

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 (DCTR-Wide)

Series: Physician (0602)

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

Telework Eligible: Yes – as determined by agency 

policy.

Work Schedule: Full Time

Cures Band: C

Salary: Starting at $165,000and is set commensurate with education and 

experience. 

Travel Requirements: 25% or less

Bargaining Unit: 3591

Full Performance Band Level: C 

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 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. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant 

impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the 

Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the 

United States.

The mission of the Center for Biologics Evaluation and Research (CBER) 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. 

The Office of Vaccines Research and Review (OVRR) protects and enhances public health by assuring those available vaccines, 

allergenic extracts, and related product are safe and effective. 
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The Division of Clinical and Toxicology Review (DCTR) directs and performs the review process for investigational new drug (IND) 

applications, biological license applications (BLAs), and amendments with regard to biological drug products regulated by the Office. 

DCTR coordinates the processing of INDs and BLAs through the other Divisions within the Office and coordinates licensing activities 

among the Divisions. DCTR develops policies and procedures applicable to the review of preclinical information, clinical trial design, 

and data submitted in support of BLAs and INDs. 

Duties/Responsibilities

The Physician conducts clinical reviews and requires a scientific medical knowledge of the infectious diseases and allergy and 

immunology diseases being treated. The incumbent makes judgement in evaluating adverse events; understanding of clinical trial 

design and determines whether products are safe and effective for human use. 

The Physician performs reviews, analysis and evaluation of safety and effectiveness of vaccines and related biologic and 

biotherapeutic products based upon scientific information from clinical trials. Conducts the preliminary evaluation and design of 

clinical trial methodology relating to clinical investigations.

Specifically, the Physician will:

 Complete preliminary clinical reviews, assignments and projects related to regulated products that have a national or 

international impact on health. 

 Review the safeguards for testing experimental and/or use of approved products in humans. 

 Review primary functions and activities concerned with labeling, advertising, post-market monitoring, adverse reaction 

evaluation, improvement of research and evaluation practices.

 Maintain cutting edge expertise of the “state of science” to incorporate the most advance theories and practices in clinical 

medicine, into the Division’s and Branch’s pre-market review activities.

 Evaluate plans and protocols to conduct tests and clinical trials of Investigation New Drugs (INDs) in humans, submitted to 

the Agency, and application amendments. 

 Evaluate clinical trial reports in humans for evidence of safety, immunogenicity, and effectiveness of new preventive 

vaccines and biotherapeutic products submitted in support of new Biologic License Applications (BLAs).

 Provide advice and guidance regarding those aspects of the application which fall within the incumbent’s area of review 

expertise. 

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 newhires 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 Clearanceis 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 below Education/Graduate Training Requirements 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. 
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Education/Graduate Training Requirements:

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

equivalent.

AND

Graduate Training:In addition to a degree, a candidatemusthave had atleastone yearof supervised experience providing direct 

servicein a clinicalsetting. Forpurposes ofthisstandard, graduate training programsincludeonly those internship, residency, and 

fellowship programs that are approved by accrediting bodies recognized within the United States or Canada.

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. 

Desired Education, Experience, or Skills:

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

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 officesponsored 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). EVerify 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), copy of your unofficial transcripts (if 

applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), SF50 (if applicable), 

latest signed PMAP (if applicable), and letter of interest with “CBER/OVRR/DCTR Physician Cures AnnouncementMonth/Year (XX/XXXX)” 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.