Employer: Oak Ridge Institute for Science and Education
*Applications will be reviewed on a rolling-basis.A research opportunity is available in the Office of New Drugs/Immediate Office, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.This project will research the use of standardized electronic toxicology study SEND datasets to develop quantitative structure activity relationship (QSAR) models that can be used to predict various general toxicology study endpoints, e.g. hepatotoxicity, renal toxicity. These models may be useful in the toxicological qualification of compounds for which it may not be practical or feasible to conduct general toxicology studies, i.e. unstable impurities, major human metabolites, and leachables/extractables associated with the container closure system of parenteral products.Under the guidance of a mentor the participant will be trained on the following topics:The SEND data standard with respect to how it encodes toxicology study resultsThe fundamentals of QSAR analysis and model buildingDevelopment of methods to detect toxicity signals in SEND datasetsDeployment of QSAR models to predict the detection of toxicity, based on signals in SEND datasetsThis 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-2021-0610) in your email.