Texas Licensed Clinical Research Director

Job Summary

Overseeing regulatory activities related to FDA submissions for oncology clinical research, the full-time salaried Texas Licensed Clinical Research Director will provide strategic regulatory guidance and operational leadership for investigational drugs, biologics, and devices while ensuring compliance with FDA regulations and institutional policies.

Key Responsibilities

• Develop targeted regulatory strategies for oncology programs across early- and late-phase clinical trials
• Serve as the primary regulatory liaison with the FDA, coordinating submissions and responses to inquiries
• Lead regulatory document management and oversee preparation of clinical protocols and regulatory submission documents

Required Qualifications

• Master's degree in life sciences, pharmacy, medicine, or a related field preferred; Bachelor's degree required
• Eight years of regulatory affairs experience with FDA submissions and oncology clinical research, including two years of lead project management experience
• Demonstrated experience preparing and managing INDs and/or IDEs
• In-depth knowledge of FDA regulations, ICH guidelines, and GCP requirements
• Preferred: RAC - Regulatory Affairs Certification