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  5. Pharmacologist Careers at CDER
  1. Jobs at the Center for Drug Evaluation and Research (CDER)

Pharmacologist Careers at CDER

Work for the FDA's Center for Drug Evaluation and Research (CDER)

What do Pharmacologists do at CDER?

The duties of a Pharmacologist 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 as proof-of-activity for use of medicinal products in patients, and (2) safety of medicinal products for use in patients and healthy subjects.
  • Participating as a subject matter expert during inspections of bioanalytical facilities or GLP laboratories involved in conducting bioequivalence and non-clinical safety studies, respectively, which are submitted to the FDA in support of drug applications. Collaborating with international regulatory agencies in inspections and detection of data anomalies in bioequivalence studies.
  • Directing and coordinating with the Office of Regulatory Affairs in the inspection of clinical sites for studies in support of INDs, NDAs, ANDAs, and BLAs.
  • Providing clinical pharmacology evaluations of therapeutics at pre- and post-approval stages, including but not limited to pharmacokinetics, pharmacodynamics, metabolism, pharmacogenomics, bioavailability/ bioequivalence, exposure–response analysis, optimal dosing in general and specific populations, and evaluation of effect of specific intrinsic and extrinsic factors.
  • Reviewing clinical and nonclinical data for regulatory compliance to ensure human subject safety and data integrity and communicating findings with a multi-disciplinary review team. Evaluating nonclinical sections of product labeling and making regulatory recommendations.
  • Reviewing biopharmaceutics information at pre- and post-approval stages, including but not limited to in vitro drug dissolution specifications, in vitro/in vivo correlations (IVIVCs), physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications, scientific bridging strategies, and biowaivers.
  • Completing special projects that involve specific research areas and objectives to include the design, characterization, performance, and bioequivalence of complex drug products; development of advanced manufacturing approaches for drug substances and drug products; development of science-based drug quality standards; and the development of analytical and in-vitro methods to support product quality surveillance and investigate product quality failures.
  • Serving as a CDER resource 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 work; and acquire background information pertinent to the conduct of divisional responsibilities.
  • Publishing scientific articles within the scientist's area of expertise and maintaining contact with the “state of science” to identify and integrate the most advanced research theories and/or practices into the Center’s drug regulatory programs.

Related positions include:

How can I find a Pharmacologist 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: 0405 - Pharmacology.
  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.

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