A complete application consists of:
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity in your email.
A research opportunity is available with the Office of Biostatistics and Epidemiology (OBE) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The successful candidate will participate in the development of a quantitative key event relationships model to simulate and predict immune responses of Chimeric Antigen Receptor (CAR) T cells. The end goal of this project is the development of a computational tool to enhance efficacy and safety evaluation of current and next-generation of engineered therapeutic products, leading to personalized, optimal treatment regimens for patients undergoing CAR T cell therapy. Under the guidance of a mentor, the participant will help develop and apply novel techniques to model and simulate interactive cellular components of CAR T Cells, as well as perform literature reviews, data collection/database curation, model development, presentation of research results, and preparation of scientific manuscripts.
*Although the application deadline is September 2, applications will be reviewed on a rolling-basis.
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, MD, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
The Homeland Security Presidential Directive-12 (HSPD-12) mandates a background check be completed for both U.S. Citizens and foreign nationals. Foreign nationals must have resided in the U.S. for at least three (3) of the past five (5) years in order for FDA to be able to complete a background check.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
The qualified candidate should have received a doctoral degree in one of the relevant fields, or be currently pursuing the degree and will reach completion by June 1, 2019. Degree must have been received within five years of the appointment start date.
Preferred skills/experience:
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