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) 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 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

How to Apply

Submit resume or curriculum vitae with cover letter by October 11, 2024, to CDER-ONDPharmTox.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: 24-045LIN in the email subject line.

Announcement Contact

For questions regarding this Cures position, please contact OND’s PharmTox Staff at CDER-ONDPharmTox.Employment@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.

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Biologist