What do Toxicologists do at CDER?

The duties of a Toxicologist at CDER differ by office. Opportunities may include:

  • Reviewing in silico, in vitro, ex-vivo, in vivo, and animal and human data submitted in Investigational New Drug (IND) Applications, New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Biologics 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.
  • Reviewing nonclinical data and communicating safety findings with a multi-disciplinary review team. Evaluating nonclinical sections of product labeling and making regulatory recommendations.
  • Serving as a CDER resource for nonclinical safety assessments by participating in work groups or subcommittees.
  • Attending meetings, conferences, and symposia of scientific organizations to remain aware and gain an understanding of developments in the field, exchange ideas with other scientific peers engaged in related areas, and acquire background information pertinent to the conduct of divisional responsibilities.
  • Meeting with industry representatives to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplement, or report which fall within area of review, with emphasis on nonclinical studies to support NDA, BLA, or ANDA submissions.

Related positions include:

How can I find a Toxicologist position at CDER?

Available CDER positions are listed on USAJOBS and under the FDA 21st Century Cures Act Hiring Authority.

  1. Search USAJOBS by Keyword: CDER. You can filter your search by Agency: Food and Drug Administration and Series: 0415 - Toxicology.
  2. Visit We Are Hiring | FDA to find a current listing of opportunities utilizing the FDA 21st Century Cures Act Hiring Authority.

Where can I learn more about careers at the FDA?

For general information on working at the FDA and additional employment opportunities, visit: Jobs and Training at FDA.