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Job Title: FDA Oncology Drug Product Dose Selection Fellowship
Job Number:
Organization: US Food and Drug Administration (FDA)
Posted: 1/9/2022
Type: Full-Time
Classification:
Industry:
Number of Openings: 1
Location: Silver Spring,  MD    USA
Compensation:
Position Description: *Applications will be reviewed on a rolling- basis.

A research opportunity is available in the Office of Translational Sciences/ Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland. 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 FDA, CDER regulates over-the- counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

The project will identify the dose-finding strategies employed during oncology drug product development over the past decade, analyze the data summarized in the marketing application used to justify the recommended dosage and the dose commonly used in clinical practice following approval, and identify the key limitations in past dose selection practices in order to refine and streamline regulatory recommendations that leverage all available data to better select doses for development. Under the guidance of a mentor, the participant will learn to prepare a database describing information gathered from multidisciplinary regulatory reviews completed during clinical development and following submission of the marketing application and publicly available sources, including published literature and compendia. The participant will also learn the current approaches used to select the dosing regimen(s) incorporated into clinical trials designed to assess safety and effectiveness and support a marketing application.

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 three 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.

Qualifications: The qualified candidate should be currently pursuing or have received a bachelor's, master's or doctoral degree (PhD, DPH, PharmD, MD) in one of the relevant fields. Degree must have been received within the past five years.

Organization Description:

Closing Date: 4/9/2022
Desired Starting Date:
Contact Name: N/A N/A,  FDA Oncology Drug Product Dose Selection Fellowship
Contact Location:

    
Contact Location:
 
      
 
Contact Phone:  
Contact Fax:
Contact Email: ORISE.FDA.CDER@orau.org
Web Address: https://www.zintellect.com/Opportunity/Details/FDA-CDER-2022-0772
How to Apply: Applications must be completed in Zintellect at the Web Address provided.

Additional Information:

Web Site Delete Date: 4/9/2022