*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of the Center Director/ Immediate Office (IO), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project will explore patient-focused drug development (PFDD): a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured, and meaningfully incorporated into drug development and evaluation. OCD, IO at CDER has been working to facilitate the incorporation of patient input into drug development and decision-making. CDER is facilitating the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical products. This project will help to enhance scientific approaches that aid in developing new drugs or evaluating their pre-market safety and efficacy.
Under the guidance of a mentor the participant will train on performing research related to implementation of patient-focused activities; assist with the evaluation of the use of patient experience data in regulatory review; provide support for patient-focused drug development meetings, which involves stakeholder engagement, and collecting and analyzing public input. This training relates to our public health mission and will assist the fellows’ understanding of types of patient experience data that are submitted to the Agency and how that information may be used to inform drug development and regulatory decisions.
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 (FDA-CDER-2021-0612) in your email.