4 months ago
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), located in Silver Spring, Maryland. CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
The project is interested in applying modeling and simulation to address specific questions in specific populations, e.g. in pediatrics and pregnancy. For example, we propose to use physiologically based pharmacokinetic modeling to predict drug disposition in pregnant women. Under the guidance of the mentor, the participant will be learning modeling and simulation techniques, and regulatory and clinical knowledge in drug development.
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 two years, 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.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA Ethics Requirements
If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.
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 or be pursing a doctoral degree in one of the related fields. Degree must have been received within the past five years.
Employer Job ID: FDA-CDER-2023-1308
Required graduation year
2018 - 2023
About Oak Ridge Institute for Science and Education
Skills you'll need for this internship
provided by employer
What happens after you send in your application?
Oak Ridge Institute for Science and Education has not provided an expected interview date. Due to the volume of applications, Oak Ridge Institute for Science and Education has indicated that they will not follow up unless you are selected for an interview.
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56 other majors78%
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For Mideast region
Typical pay range:
$18.63 - $23.95
For Silver Spring, MD | $5,379/mo
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