*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available with the Office of the Commissioner (OC) Office of Women’s Health (OWH), U.S. Food and Drug Administration (FDA). The project will be located at the Center for Drug Evaluation and Research (CDER) located in Silver Spring, Maryland.
The objective of the current project is to evaluate the recommended dosing of approved antimalarial drugs and proposed dosing of investigational antimalarial drugs in pregnant women infected with malaria. Model-informed drug development (MIDD) approaches will be used to characterize physiologic changes during pregnancy and the potential effect of those changes on efficacy and safety. The results of this project will support regulatory decision making on dose recommendations for approved and investigational antimalarial drugs in pregnant women and provide guidance for clinical study design to expedite antimalarial drug development in this population.
The participant will have the opportunity to learn the antimalarial drug development from a regulatory perspective. The participant will utilize the modeling and simulation approaches to support dose optimization and efficient drug development in pregnant patients with malaria.
Anticipated Appointment Start Date: Winter 2021/2022
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.OC.email@example.com. Please include the reference code for this opportunity in your email.