Biopharmaceutics Sub-Classification for Food Effect Prediction Fellowship - FDA CDER

- Silver Spring, MD4.0

Full-timeEstimated: $66,000 - $86,000 a year
EducationSkillsBenefits
Organization U.S. Food and Drug Administration (FDA)
Reference Code FDA-CDER-2019-0392
How to Apply

A complete application consists of:
An application
Transcripts – Click here for detailed information about acceptable transcripts
A current resume/CV, including academic history, employment history, relevant experiences, and publication list
One educational or professional recommendation. Your application will be considered incomplete, and will not be reviewed until one recommendation is submitted.
All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.

Application Deadline 5/8/2019 3:00:00 PM Eastern Time Zone
Description
A research opportunity is available in the Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

OCP's Division of Pharmacology II (DCPII) evaluates clinical pharmacology protocols and data submitted in INDs/NDAs/BLAs, and is currently developing an elimination pathway-based biopharmaceutics sub-classification system to improve the prediction of Food Effect (FE). During this project OCP DCPII will collect data and generate scientific evidence to support complete or partial waiver of clinical food effect studies for the development of certain sub-classes of Biopharmaceutics Classification System class I (BCS I) and class III (BCS III) drugs.

Under the guidance of a mentor the participant will train on data collection, analysis, BCS sub-classification, physiologically-based pharmacokinetic (PBPK) simulation, and manuscript preparation. This experience will significantly enhance the participant's overall training and development as a scientist.

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.

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:

Non-employee nature of the ORISE appointment;
Prohibition on ORISE Fellows performing inherently governmental functions;
Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
The fact that research materials and laboratory notebooks are the property of the FDA;
ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
Qualifications
The qualified candidate should be currently pursuing or have received a doctoral degree in pharmacokinetics-related majors such as pharmaceutical sciences. Degree must have been received within five years of the appointment start date.

Preferred skills:
Strong educational background in pharmacokinetics and drug ADME
Publication history in peer reviewed journals
Eligibility Requirements
Degree: Doctoral Degree received within the last 60 months or currently pursuing.

Discipline(s):
Life Health and Medical Sciences (47 )