FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

About the role

The FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship offers a unique opportunity to engage in cutting-edge research aimed at evaluating drug safety and supporting regulatory decision-making. The research project focuses on utilizing nonclinical in vitro studies and advanced statistical modeling to assess the safety of new drugs.

Responsibilities

• Conducting state-of-the-art automated patch clamp electrophysiology experiments to evaluate drug effects on cardiac and neuronal ion channels.
• Developing and applying advanced statistical models for data analysis related to drug safety.
• Contributing to the development of innovative translational strategies to leverage in vitro data in drug development.
• Presenting research findings at internal and external scientific conferences.
• Writing high-impact scientific manuscripts based on research conducted during the fellowship.

Requirements

To qualify, candidates must:

• Be currently pursuing or have received a doctoral degree in a relevant field.
• Be a U.S. citizen or have lived in the United States for at least 36 out of the past 60 months.
• Have read and signed the FDA Education and Training Agreement.

Qualifications

Preferred qualifications include:

• Experience with automated patch clamp electrophysiology.
• Knowledge of advanced statistical modeling techniques.
• Interest in regulatory science and its impact on drug development.

Skills

Essential skills include:

• Strong analytical and problem-solving abilities.
• Excellent communication and presentation skills.
• Ability to work independently and collaboratively.

Benefits

The fellowship provides:

• A monthly stipend commensurate with educational level and experience.
• Opportunities to present research results at scientific conferences.
• Hands-on experience in regulatory science methodologies.
• Comprehensive knowledge of FDA regulatory policies and regulations.

Pay

The stipend is determined based on the candidate's educational level and experience.

Schedule

The appointment is full-time and initially for one year, with the possibility of renewal contingent on funding availability.