FDA Pulmonary Drug Effectiveness Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of New Drugs / Office of Drug Evaluation II, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
As part of FDA’s broader initiative to use real world data from the Sentinel Distributed Database to inform regulatory decision-making, DPARP proposes to use Sentinel data to answer clinical effectiveness questions in obstructive lung disease. This project will perform analyses of drug administration data in Sentinel data. Combined with clinically impactful effectiveness endpoints of disease exacerbation and hospital utilization data, this could inform regulatory effectiveness decisions on new indications, new efficacy claims, and new populations for pulmonary drugs using real world evidence.
The participant will have an opportunity to learn from a multidisciplinary team of experts including FDA physicians, pharmacoepidemiologists, and clinical pharmacologists with experience in real world evidence, data science, and regulatory decision-making. The participant will gain experience in the design, conduct, and interpretation of real world evidence (RWE) observational studies.
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.
Qualifications
The qualified candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0539) in your email.