*Applications will be reviewed on a rolling- basis.
A research opportunity is currently available in the Office of New Drugs / Office of Drug Evaluation Sciences (ODES), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland. 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 FDA, CDER regulates over-the- counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
The project will gather evidence to qualify serum alanine aminotransferase (ALT) as a safety biomarker for the context of use (COU) of detecting potentially serious drug-induced liver injury (DILI) with superior performance to the current practice of applying different upper limit of normal (ULN) which have increased over time and vary from study to study.
Under the guidance of the mentor, the participant will gain knowledge in regulatory data standards and how they pertains to the evaluation of DILI. The participant will also gain valuable experience in FDA safety evaluation and how safety analytics can be used to identify potential subjects at risk for DILI. The participant will also have opportunities to present the findings of the study to the scientific community internally and externally as well as to publish the findings in a peer reviewed journal.
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.