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
10/31/2021 3:00:00 PM Eastern Time Zone
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
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 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 master’s or doctoral degree in one of the relevant fields. Degree must have been received within the past five years.
- Interest in chemistry, informatics, data science or related disciplines
- Administrative skills
- Degree: Master’s Degree or Doctoral Degree received within the last 60 month(s).
- Communications and Graphics Design
- Computer, Information, and Data Sciences
- Life Health and Medical Sciences
- Other Physical Sciences