*Applications will be reviewed on a rolling basis.
An opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) in Silver Spring, Maryland.
This project located in the Office of Translational Science (OTS) Office of Clinical Pharmacology (OCP) will develop and validate animal models that can improve FDA’s ability to predict and characterize potential clinical issues in metabolism, safety and product quality using animal models prior to human testing. Under the direction and guidance of a mentor, the participant will have the opportunity to learn how to use advanced genomics and other -omics or big data technology, such as next generation sequencing (NGS) and cutting-edge bioinformatics methods, to evaluate a drug’s therapeutic efficacy and/or safety. They will then apply this data mining/machine learning approach to decision making during drug development or regulatory assessment.
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 in your email.