*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Translational Sciences, Office of Clinical Pharmacology located in Silver Spring, Maryland.
The continuous rise of antimicrobial resistance is an urgent public health problem. New antibacterials are being developed to target drug-resistant pathogens; however, current clinical trials do not appear to focus on resistance suppression. The objectives of this project are to assess alignment between nonclinical and clinical studies and to formulate best practices for nonclinical studies to support translation to clinical development.
Under the guidance of the mentor, the participant will gain familiarity with the anti-infective clinical development process, become aware of the impact of various disciplines (including clinical pharmacology and clinical microbiology) on drug development, and understand different modalities of nonclinical studies used to support drug development. In addition, the participant will also improve their ability to investigate, analyze, and assess data from various sources.
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.