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.
- Search USAJOBS by Keyword: CDER. You can filter your search by Agency: Food and Drug Administration and Series: 0405 - Pharmacology.
- 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.