Title 21 Cures Vacancy Announcement

U.S. Department of Health and Human Services (HHS) 

Food and Drug Administration (FDA)

Center for Drug Evaluation and Research (CDER)

Office of New Drugs (OND)

Pharmacology/Toxicology Divisions (PTD)

Application Period: January 24, 2024 - February 23, 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: Biologist Series: AD-0401

Location(s): Silver Spring, MD

Work Schedule: Full-Time

Salary: $117,962 - $165,260

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

Travel Requirements: 25% or less

Bargaining Unit: 3591

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 careerconditional 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) 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.

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 (OTC) and prescription 
2

drugs, including biological therapeutics and generic drugs. 

The Office of New Drugs’s (OND) public health mission is to protect and enhance the health of 

the public through the review and evaluation of scientific data submitted by pharmaceutical 

manufacturers in support of both New Drug (NDA) and Investigational New Drug applications 

(INDAs), and to determine if candidate drugs are safe and effective.

Duties/Responsibilities

As a Biologist, the incumbent is responsible for reviewing and evaluating drug applications and 

communicating conclusions with a multidisciplinary review team. The work will be performed 

within any of the pharmacology/toxicology or clinical drug review divisions located within OND.

• Reviews nonclinical data and communicates safety findings, evaluates nonclinical 

sections of product labeling, makes regulatory recommendations, and meets with 

industry representatives. 

• Serves as a CDER resource for nonclinical safety assessments participating in work groups 

or subcommittees.

• Reviews in silico, in vitro, ex-vivo and animal data submitted to IND Applications, NDAs, 

and Biological License Applications (BLAs) to evaluate: (1) mechanism of action (MOA) as 

proof-of-activity for use of medicinal products in patients, and (2) safety of medicinal 

products for use in patients and healthy subjects.

• Uses non-clinical data to recommend a first-in-human (FIH) dose range that is safe within 

the clinical trial context and therapeutic in patients. Employs advanced scientific 

knowledge for human dose selection that integrates medicinal products' pharmacology, 

molecular and cellular biology. Mathematical modeling maybe employed for human dose 

selection, as needed.

• Evaluates whether non-clinical sections of product labeling have accurate and adequate 

information to communicate the safety and risks of use to patients. Information in the 

product labeling to be evaluated include, but are not limited to, genotoxicity, 

carcinogenicity, and reproductive safety (fertility, embryofetal, and postnatal 

development) of the drug, and duration of contraception where applicable. Collaborates 

with other Divisions or Offices and Centers, as appropriate.

Supervisory Responsibilities: N/A

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, 
3

you must take affirmative steps to resolve the matter.

• Males born after December 31, 1959, must be registered with the Selective Service.

• One-year 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.

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: 

Biologist, AD-0401 Series 

For more information, please see: OPM Occupational Series Qualification Requirements.

Desired Professional Experience: 

Our ideal candidate will possess experience in molecular, cellular or systems biology, 

pharmacology, and toxicology.

Desired Education: 

Our ideal candidate will possess a doctorate degree and specialized experience in neuroscience, 

immunology, pathology, cancer/molecular biology, or ophthalmology from an accredited 

university are highly encouraged to apply. 

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 
4

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 Recognition of Foreign 

Qualifications | International Affairs Office (ed.gov)

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: Non-Sensitive/Moderate Risk

If not previously completed, a background security investigation will be required for all

appointees. Appointment will be subject to the applicant’s successful completion of a

background security investigation and favorable adjudication. Failure to successfully meet these

requirements may be grounds for appropriate personnel action. In addition, if hired, a 

background security investigation or supplemental investigation may be required later. 

Applicants are also advised that all information concerning qualifications is subject to

investigation. False representation may be grounds for non-selection and/or appropriate

disciplinary action.

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 
5

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 accommodation to have an equal 

opportunity to apply for a job. An employee with a disability needs accommodation to perform 

the essential job duties or to gain access to the workplace. An employee with a disability needs 

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.

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 with cover letter by February 23, 2024, to CDERONDPharmTox.Employment @fda.hhs.gov. Candidate resumes may be shared with hiring officials 

within the Center for Drug Evaluation and Research with a similar job vacancy. Candidates can opt 

out of this process by annotating resume with “do not share”.

Please reference Job Reference Source Code ID: 24-016LIN in the email subject line.

Announcement Contact

For questions regarding this Cures position, please contact OND’s PharmTox Staff at CDERONDPharmTox.Employment @fda.hhs.gov.

The U.S. Department of Health and Human Services is an equal opportunity employer with a 

smoke free environment.

FDA is an equal opportunity employer.