FDA Research Opportunity - Dosing of Cancer Drugs in Obesity

About the role

The FDA Office and Location is the Center for Drug Evaluation and Research (CDER) in White Oak, Maryland. The Center focuses on ensuring safe and effective drugs are available to improve public health.

Responsibilities

• Engage in comprehensive data analysis of oncology clinical trials to examine dosing, efficacy outcomes, and safety profiles across different body mass index categories.
• Collaborate with FDA scientists to analyze existing clinical trial data, investigate dosing methodologies, and contribute to the development of evidence-based guidance for oncology drug dosing in patients with obesity.
• Gain hands-on experience with data analysis/platforms and knowledge of regulatory science and oncology drug development.
• Participate in Office and Division-level clinical pharmacology training modules/programs.
• Build a professional network within FDA and the broader regulatory science community through collaboration with multidisciplinary teams including clinical pharmacologists, oncologists, and regulatory reviewers.
• Contribute to peer-reviewed publications, scientific presentations at conferences.

Requirements

This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.

Qualifications

• Currently pursuing or have received a bachelor's, master's, or doctoral degree in relevant fields.
• U.S. citizen or have lived in the United States for at least 36 out of the past 60 months.

Skills

Knowledge of clinical pharmacology principles specific to oncology drug development and population-specific dosing considerations, ability to analyze complex clinical trial datasets, and understanding of FDA's drug review process.

Benefits

No specific benefits are mentioned in the job posting.

Pay

The participant will receive a monthly stipend commensurate with educational level and experience.

Schedule

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.