*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Translational Sciences/ Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
The Center for Drug Evaluation and Research (CDER) performs 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. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
Atypical pharmacokinetic or pharmacodynamic characteristics of a clinical pharmacology study compared to the overall patient population often indicate underlying factors that are unique to the study, such as study design, assay methodology, formulation, patient population. Or they are attributed to pharmacological mechanism of the drug, for example: dose nonlinearity, immunogenicity, and receptor mediated metabolism. Meta-analysis methods will be developed and implemented to investigate anomalies in pharmacokinetics or pharmacodynamics of clinical pharmacology studies by comparing multiple study outcomes in a drug application submission. The root causes of the anomalies will be determined and summarized by drug class or therapeutic area.
Under the guidance of the mentor, the participant will learn to develop meta-analysis methodology and perform analyses to identify anomalies in pharmacokinetic or pharmacodynamic characteristics of clinical pharmacology studies in NDA/BLA submissions. The participant will also obtain knowledge and key concepts related to the FDA NDA/BLA review process.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0714) in your email.