Director, Gene Therapy Clinical Science

Role: Director, Gene Therapy Clinical Science overseeing early-phase clinical development for gene therapies targeting rare, life-threatening diseases. Responsibilities include leading clinical science teams, managing clinical study design, execution, and reporting, and providing medical/clinical input on protocols, safety assessments, and data analysis. The role involves building relationships with investigators, ensuring compliance with GCP standards, and contributing to scientific publications and regulatory documents. The position also requires cross-functional collaboration with research, regulatory, manufacturing, and medical affairs teams, and oversight of Data Monitoring Committees.

Qualifications: Nursing degree required, with MSN and 10+ years or BSN and 12+ years of progressive experience in clinical research, preferably in cell or gene therapy within the pharma industry. Knowledge of global/regional regulations, ICH/GCP, adverse event management, and clinical data review essential. Must demonstrate strong leadership, communication, and collaborative skills.

High-Value: Focus on gene therapy, early-stage development (First in Human through proof of concept), with emphasis on rare diseases. The candidate should have experience in clinical trial design, safety monitoring, and regulatory interactions within GxP environments.

Work setup: Not specified; likely hybrid or onsite based on standard industry practices. Travel requirements are not explicitly stated.