*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Translational Sciences/ Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER), Food and Drug Administration 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.
This project aims to develop a central location where reviewers can search by chemical structures to determine if an impurity is already known to the Agency and had been previously evaluated by the Computational Toxicology Consultation Service. All of the various studies on a single chemical that were submitted under different drug applications, under different drug substances, and/or under different names will be linked under this effort. This eliminates repeat (Q)SAR consultation requests for impurities that have already been evaluated and ensures consistency in regulatory decision-making.
Under the guidance of mentor, the participant will have the opportunity to learn about cheminformatics in the regulatory setting. In addition, the participant will learn to:
- Extract and harmonize data from experimental Ames studies
- Register and catalog unique chemical structures
- Navigate commercial, proprietary and publicly available chemical databases
- Perform chemical structure queries (global and substructure)
- Link chemical structures to experimental data
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 six months, 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