This position is located in the Division of Biochemical Toxicology, National Center for Toxicological Research, Food and Drug Administration in Jefferson, Arkansas. The Division of Biochemical Toxicology is responsible for planning and directing research specifically designed to define biological mechanisms of action underlying the toxicity of products either regulated by, or of interest to, the product Centers of the Food and Drug Administration (FDA). The risk assessment research is firmly rooted in mechanistic and computational studies focused on the understanding of toxicological endpoints, an approach that allows for greater confidence in risk assessments for carcinogenic, reproductive and endocrine active drugs or chemicals. Research within the Division of Biochemical Toxicology capitalizes on scientific knowledge in the areas of biochemistry, organic chemistry, analytical chemistry, cellular and molecular biology, nutritional biochemistry, toxicology, pharmacology, and computational modeling.

Responsibilities

The Division of Biochemical Toxicology of the U.S Food and Drug Administration’s National Center for Toxicological Research (NCTR) has a Staff Fellow/ Visiting Scientist position open immediately. The primary emphasis of the research protocol is to develop a multi-route physiologically-based pharmacokinetic (PBPK) model for nicotine and metabolites based on an in-house experimental PK dataset in rats. These results will provide an improved understanding of the health risks associated with exposure to tobacco products regulated by the FDA and will contribute to regulatory decisions concerning safety aspects of these products. The candidate will work with the team leader. Project duties will include, but are not limited to, the following:

• Conducting PK analyses, parameter sensitivity analyses, and Monte Carlo simulations for predicting all organ, tissue, plasma, and urine concentrations of nicotine and metabolites.
• Planning and implementing research projects in computational modeling, as well as designing and developing new computational methods to support experimental toxicology protocols.
• Defining testable hypotheses, devising suitable experimental and computational strategies, and interpreting the results in regard to specific goals and to the broader field of toxicology and risk assessment.
• Writing manuscripts for peer-reviewed publication in scientific journals and presenting at scientific meetings.
• Helping review and evaluate manuscripts, protocols, etc. and participating in advisory functions and committees as requested.
• Interacting with colleagues throughout the Agency as a subject matter expert in support of the FDA research and missions.

Qualifications

Candidates must have a doctoral-level degree from an accredited institution of higher learning, including: Ph.D. or equivalent degree in relevant field.

The candidate should have demonstrated experience in PK analysis, PBPK modeling, or statistical modeling using state-of-the-art computational software.

The ideal candidate will have an interest and desire to learn the development and application of computational models for risk assessment and will be provided adequate support and training for best practices in writing efficient model codes and mass balance differential equations, data visualization, and statistical modeling.

Experience in computational biology and computational methods, such as whole-body physiological modeling or in vitro modeling of systems would be a plus. The incumbent will be trained to apply these techniques to address biological problems that are important to the regulatory mission of the FDA.

How to Apply

Candidates must submit a CV and brief statement of interest to:

Darshan Mehta

National Center for Toxicological Research

3900 NCTR Road

NCTR-53C RM204G HFT-110

Jefferson, Arkansas 72079

Email: Darshan.Mehta@fda.hhs.gov