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
• Two educational or professional references

All documents must be in English or include an official English translation.

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

A postdoctoral fellowship opportunity is currently available in the Division of Biochemical Toxicology (DBT) at the National Center for Toxicological Research (NCTR) of the U.S. Food and Drug Administration (FDA) Jefferson Laboratories Campus located in Jefferson, Arkansas.

NCTR conducts FDA mission-critical research specializing in the development of scientific strategies to support regulatory decision-making. DBT focuses on fundamental and applied research designed to support risk-assessment for chemicals of interest to the FDA. The participant will become a part of DBT’s Computational Modeling Group, which develops and uses pharmacokinetic, pharmacodynamic and dose-response models to describe the multifaceted biological system-compound interactions in support of NCTR’s objectives and the FDA mission.

The participant will be involved in a project to:

• Develop physiologically based pharmacokinetic (PBPK) models for pre-pregnancy and pregnancy stages in animal models and humans to investigate the effects of pregnancy-related alternations in the disposition of candidate drugs.
• Characterize inter-species differences, and human and life-stage specific differences to derive cross-species and intra-population extrapolation strategies.
• Use developed methodologies and available modeling and simulation tools to conduct comprehensive analysis of the experimental data.
• Apply probabilistic approaches to estimate the uncertainties and variabilities in PBPK model predictions.

Through this project, the participant will have the opportunity to learn and apply computational modeling skills, including PBPK modeling, and use various modeling platforms to address public health-related issues and gain experience in developing tools geared towards the advancement of regulatory science. S/he will collaborate with FDA investigators at NCTR and with investigators in other FDA centers. During the project, s/he will be actively encouraged to present the research at internal and external meetings and publish findings in peer-reviewed journals.

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 education level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at NCTR in Jefferson, Arkansas. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.

• A doctoral degree in pharmacology, toxicology, pharmacokinetics, biological sciences, applied mathematics, bioengineering or a related discipline, received within the last five years.
• Experience in pharmacokinetic (PK), PBPK, PK/PD modeling, systems biology, mathematical or statistical modeling is desired.
• Experience in the use of any modeling and simulation softwares (e.g. acslX, Matlab, Simcyp, GastroPlus, WinNonlin, etc.).
• Knowledge of pharmacokinetic and toxicological principles is preferred.

• Degree: Doctoral Degree received within the last 60 month(s).
• Discipline(s):
  • Engineering (1 )
  • Life Health and Medical Sciences (3 )
  • Mathematics and Statistics (1 )