*Applications will be reviewed on a rolling basis.
A research opportunity is currently available with the Office of Translational Sciences/ Office of Clinical Pharmacology (OCP) at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) located 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 examine issues related to scientific and regulatory best practices in the dose selection and optimization, therapeutic individualization, and benefit/risk balance in patient subpopulations. The project will help inform the development of both scientific and regulatory best practices in therapeutic individualization and model informed drug development.
Under the guidance of a mentor, the participant will learn how to incorporate clinical pharmacology principles into therapeutic individualization and drug development. The participant will also learn how to design and propose regulatory research; then conduct and summarize the study results.
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.