Title 21 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 Translational Sciences (OTS)

Office of Clinical Pharmacology (OCP)

Application Period: January 29, 2024 – February 9, 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: Pharmacokineticist Series: AD-0401

Location(s): Silver Spring, MD 

Work Schedule: Full Time

Salary: Starting at $132,368

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

Travel Requirements: 25% or less

Bargaining Unit: 8888

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 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 

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 
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health of people in the United States. CDER regulates over the counter (OTC) and prescription 

drugs, including biological therapeutics and generic drugs. 

The mission of the Office of Translational Sciences (OTS) is to empower a diverse, collaborative, and high 

performing workforce to champion innovation and advance global human drug development.

The Office of Clinical Pharmacology (OCP) is a dynamic, purpose-driven organization dedicated 

to promoting and protecting global public health through the application of clinical 

pharmacology and translational medicine principles. OCP plays a pivotal role in advancing the 

development of innovative new medicines by applying state-of-the-art scientific principles. OCP 

promotes therapeutic optimization and individualization through best practices in research, 

policy development, and drug evaluation throughout the product lifecycle.

This position is in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), 

Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). 

Duties/Responsibilities 

As a Pharmacokineticist, the incumbent serves in the Division of Cancer Pharmacology II in the 

Office of Clinical Pharmacology Serves as a principal advisor to the Division Director, Deputy 

Division Director, and Associate Directors in a specified therapeutic area, and leads a team of 

clinical pharmacology reviewers in this therapeutic area responsible for issues pertaining to 

clinical pharmacology and biopharmaceutics reviews. Represents the Division/Office at crucial 

meetings with industry and expected to have prepared in advance for the agenda and express 

the position of the Division/Office on scientific issues in clinical pharmacology.

Responsible for planning, coordinating, and evaluating the programs and activities of the 

Division for the therapeutic area for which he/she is responsible. This responsibility requires 

close personal contact with the “state of the science and therapeutics” to include the most 

advanced theories and practices in the specific therapeutic area into the Division and Office 

programs.

Stays up to date on complex, long range, and emerging problems of drug safety, efficacy, and 

dosing, as well as conflicts in the therapeutic area as applied to the products being regulated. 

Keeps fully abreast of crucial and/or precedent setting cases, scientific and clinical 

interpretations, or analyses under review with the Division and in the regulated industry as 

well as cases in the Office.

Demonstrates awareness and knowledge of the design and analysis of human pharmacokinetic 

and pharmacodynamic studies, including single or multiple dose studies, mass balance studies, 

food effect, bioequivalence, drug-drug interactions, hepatic or renal impairment studies, QT 

prolongation studies, pediatric studies and in vitro and in vivo human metabolism and 

transporter studies including a working knowledge of PK/PD (Pharmacokinetic 

Pharmacodynamic relationships), modeling and simulation and pharmacogenomics.

Applies current knowledge of research in a particular scientific discipline and therapeutic areas 
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and research conducted by the regulated industry in therapeutic responsibility to advise 

organizational leadership of interrelated programs, current developments, and problems 

related to products under review and ensure that rapid advances in translational science such 

as quantitative clinical pharmacology and pharmacogenomics are incorporated into regulatory 

reviews. Ensures that model informed drug development (MIDD) principles are being applied in 

drug development and review. Applies knowledge of therapeutic area understanding to 

provide a medical practice context for clinical pharmacology.

Applies current knowledge of research in a particular scientific discipline and therapeutic areas 

and research conducted by the regulated industry in therapeutic responsibility to advise 

organizational leadership of interrelated programs, current developments, and problems 

related to products under review and ensure that rapid advances in translational science such 

as quantitative clinical pharmacology and pharmacogenomics are incorporated into regulatory 

reviews. Ensures that model informed drug development (MIDD) principles are being applied in 

drug development and review. Applies knowledge of therapeutic area understanding to 

provide a medical practice context for clinical pharmacology.

Demonstrates clear and concise communication skills, supplemented with training in oral and 

written communication skills and a commitment to work within the Division and across the 

other Divisions in the Office (e.g., pharmacometrics, genomics) to optimize the quality of the 

drug review(s) applicable to the specialized therapeutic area(s).

Recognizes authority and lead in the specific therapeutic area, is expected to resolve unique, 

far reaching, and previously unresolved problems, design/recommend studies relating to 

specific drug issues, and consults with other professionals both within and outside the Federal 

government as necessary.

Ensures timely and effective communication with the sponsors. The incumbent ensures timely 

completion of reviews by his/her team members according to GRMP (Good Review 

Management Principles) timelines.

Coordinates and manages the work assigned to the team in a specific therapeutic area with the 

objective of assuring timely, high quality and efficient review. Sets priorities and coordinates 

work in the specific therapeutic area. The incumbent assures uniformity and consistency in the 

development of policies and procedures governing clinical pharmacology and 

biopharmaceutics review. Develops active cooperation and productivity of the therapeutic area 

for which he/she is responsible. Counsels, mentors, and supports the professional 

development of their respective team of reviewers in this therapeutic area and personally 

explains critical and significant scientific concepts.

Leads or serves as a member of Division/Office task forces and study groups called together to 

consider general problems and/or specific solutions for issues surrounding various drug 

products.

Supervisory Responsibilities: N/A
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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 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:

A bachelor’s degree or higher in statistics, engineering, mathematics, physics, chemistry, data 

science, computer science, clinical pharmacology, pharmaceutical sciences, pharmacometrics, 

pharmacy, toxicology, biotechnology, or biopharmaceutics. The degree must be from an 

accredited program or institution.
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Desired Professional Experience:

Our ideal candidate will possess:

• Relevant work in the design and interpretation of pharmacokinetic studies.

• Knowledge of the use, clinical effects, and composition of medications, including their 

chemical, biological, and physical properties. Qualifying professional pharmacy 

experience may involve, but is not limited to:

o Dispensing medications prescribed by physicians and other health 

practitioners and providing information to health practitioners and patients 

about proper usage of medications and side effects.

o Evaluating medication use patterns and outcomes for patients in hospitals or 

managed care organizations.

o Performing administrative, consultative, or staff advisory work for a medical 

facility’s pharmacy program.

o Planning, monitoring, and evaluating medication programs or regimens.

o Establishing medication handling procedures for the storage and preservation of 

medications. 

o Researching medical literature and/or clinical medication information to provide 

accurate responses to inquiries; and/or

o Maintaining all medication records required by law.

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.

Security Clearance Requirements

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

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 
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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

Applicants should submit a letter of interest (cover letter) and current resume by February 9, 

2024, to CDEROTSHires@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 or email with “do not share”. 

Please adhere to the following submission protocol:

Cover letter and resume should be one combined PDF document with the following naming 

convention: Last Name, First Name. 

• Please reference Job Reference ID: ‘OCP/DCPII Pharmacokineticist in the subject line 

of the email.

How I Will Be Evaluated

Candidates may be evaluated based on an interview, review of requested work samples, writing 

samples, most recent performance evaluation(s), professional references, results of an oral 

presentation or work-related test. Failure to comply with any of the additional assessment 

requirements will result in removal from further consideration.

Announcement Contact

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