Training and Clinical Education Director jobs in Tennessee

• Applications will be reviewed on a rolling-basis.

CDER Office/Lab and Location: A research opportunity is available in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS) within the Food and Drug Administration (FDA) located 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: This project will explore the scientific and regulatory framework utilized to assess clinical pharmacology studies submitted in New Drug Applications. This background will be applied to identify and summarize complex scientific and policy issues in pivotal pharmacology studies as well as conduct regulatory research to develop policy and scientific approaches to address the identified issues.

Under the guidance of the mentor, the participant will gain an in depth understanding of the drug review process. The participant will gain experience in developing scientific and policy approaches for clinical pharmacology.

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 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 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 master's or doctoral degree in one of the relevant fields. Degree must have been received within the past five years.

The following degrees will be preferably considered:

• Doctoral Degree in Life Health and Medical Sciences
• Pharm D Degree
• Master's degree in engineering
• Master's degree in public health

The application must be completed through Zintellect. https://www.zintellect.com/Opportunity/Details/FDA-CDER-2024-1383