Connect with ORISE...on the GO! Download the new ORISE GO mobile app in the Apple App Store or Google Play Store to help you stay engaged, connected, and informed during your ORISE experience and beyond!
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
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.
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is available in the Office of Medical Policy Initiatives (OMPI), Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The Center for Drug Evaluation and Research (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 U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
Research Project: Underrepresentation of older adults (aged >= 65 years) in drug development programs has created a knowledge gap in the modifying effects of aging on drug pharmacokinetics (PK) and pharmacodynamics (PD) such that drug dosages proposed for geriatric populations are often not based on high quality evidence. Evaluating methods that are viable alternatives to clinical PK/PD studies in providing reliable information for appropriate dosing in geriatric populations is vital for ensuring the projected increase in geriatric populations will not result in a geriatric drug safety public health crisis. This project will explore the development and validation of a PBPK model for predicting drug exposures in geriatric populations and couple the geriatric PBPK model with PD models to assess the clinical utility of the geriatric PBPK model. We anticipate that our approach will provide an evidence-based guide for proposing effective and safe drug dosages for older adults in drug labeling.
Learning Objectives: Under the guidance of a mentor, the participant will be trained in database development, principles of clinical pharmacology, geriatric medicine/gerontology, and physiologically based pharmacokinetic (PBPK) modeling and simulation methods. Furthermore, the participant will be trained in how to assess the potential regulatory implications of their research findings, provided opportunities for gaining skills for effective scientific communication, and developing medical policy.
Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of Participation: The appointment is full time.
Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.
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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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:
- 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.
The qualified candidate should have received a doctoral degree in one of the relevant fields or be currently pursuing with anticipated degree completion by the appointment start date. Qualified master’s and bachelor’s level degrees may also be considered provided the candidate demonstrates strong experience in pharmacometrics. Degree must have been received within five years of the appointment start date.
- Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 months or anticipated to be received by 6/30/2024 12:00:00 AM.
- Discipline(s):
I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
and
I have read the FDA Ethics Requirements.
ORISE GO
The ORISE GO mobile app helps you stay engaged, connected and informed during your ORISE experience – from application, to offer, through your appointment and even as an ORISE alum!
