FDA Stem Cell and Electrophysiology Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of New Drugs/Office of Drug Evaluation I, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project will define data standards and a data processing pathway for in vitro ion channel data that will be used by the in silico model [3] for proarrhythmia risk assessment under the new The Comprehensive in vitro Proarrhythmia Assay (CiPA) paradigm. The Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative is developing a new paradigm for cardiac safety evaluation of drugs that combines multi-ion channel data with in silico modeling to assess proarrhythmic potential. Data standards and prototype for submission pathway and analysis will permit FDA to review data submitted to evaluate the proarrhythmic potential of new drugs.
Under the guidance of a mentor the participant will be trained on defining standard data format for high throughput ion channel data from in vitro experiments and data processing pathway/workflows. This project is important to our public health mission and the training in support of this project will prepare the participant for a successful career transition into regulatory science research.
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 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-2020-0538) in your email.