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Job

Clinical Pharmacologist Reviewer

Organization

Food and Drug Administration, Bethesda, Maryland, United States

Scientific focus area

Genetics and Genomics, Immunology, Clinical Research

The 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; that all such products marketed in the U.S. are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated.

About the position

The incumbent serves as the Clinical Pharmacologist Reviewer for the Office of Clinical Evaluation (OCE) within the Office of Therapeutic Products (OTP). This position reports to the OCE Office Director. The Clinical Pharmacologist Reviewer provides clinical, clinical pharmacology and non-clinical review and recommends appropriate action on investigational new drug applications (INDs), biologics license applications (BLAs), investigational device exemptions (IDEs), Pre-Market Approval Applications (PMAs), and 510(k) submissions pertinent to products within the Office’s purview. The incumbent provides interpretation and policy recommendations on clinical pharmacology, programs intended to support IND, BLA, IDE, PMA, and 510(k) submissions. Specifically, the Clinical Pharmacologist Reviewer will: Serve as a senior reviewer, provide scientific expertise as a member of multi-disciplinary scientific and medical teams engaged in review, evaluation, and decision-making regarding approvability of submissions and

Apply for this vacancy

What you'll need to apply

Please submit electronic resume or curriculum vitae (for each position held, please be sure to clearly define the number of years by month and year, all completed trainings, and clearly describe duties and accomplishments). Please also submit SF50 (if applicable), latest PMAP (if applicable), unofficial transcripts, Foreign Credit Evaluation (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), and letter of interest (Word or PDF) with “Title 21 CBER/OCE/IOD Clinical Pharmacologist Reviewer” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through January 27, 2025.

Contact name

CBER Human Capital

Contact email

CBERHumanCapital@fda.hhs.gov

Qualifications

Basic Qualification Requirements:

In order to qualify for this Title 21 (Cures) position, the candidate(s) must meet the following requirements:

  • Education:
    • A bachelor’s degree or higher in toxicology, pharmacology, pharmaceutics, environmental sciences, medicinal chemistry, pharmaceutical sciences, or related sciences. The degree must be from an accredited program or institution. OR
    • American Board of Toxicology certification OR
    • When there is no experience statement, follow the job family description.

Desired Professional Experience/Qualifications:

The experiences and qualifications listed below are considered preferable/desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position. Ideal candidates should have a Doctorate or a Ph.D. in a biological, medical, veterinary, pharmacology, or physical science field. Experience assessing, analyzing or evaluating study designs, data or conclusions submitted by sponsors of pharmacology or biopharm

Disclaimer/Fine Print

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional 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 further information, visit the U.S. Department of Education website for Foreign Education Evaluation. How you will be evaluated: You will be evaluated for this job based on how well you meet the qualifications above. This is a Title 21 announcement: Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. You will be evaluated against the basic

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