Director, Clinical Operations
Core
Strategic leadership and operational oversight for clinical trials from start-up through close-out, ensuring execution within budget, timelines, and regulatory requirements.
Role type
Senior IC clinical operations director
Builds
Clinical trials for engineered Tr1 cell therapies targeting autoimmune and inflammatory diseases
Domain
Biotechnology / Cell and Gene Therapy
Required skills
Clinical study management, CRO/vendor management, regulatory compliance (GCP/FDA), cross-functional team leadership, risk management, protocol development, data quality oversight, inspection readiness, strategic planning
Preferred skills
Cell and/or gene therapy trial experience, autoimmune indication experience (MS, IBD), pre-NDA/Phase 1 trial experience
Technologies
eTMF, CTMS, EDC, safety databases
Responsibilities
Lead cross-functional clinical study teams; direct CROs and vendors; oversee protocol development and regulatory submissions; manage clinical monitoring strategies; oversee data collection and quality; ensure inspection readiness; mentor clinical operations personnel
Seniority
Senior, hands-on IC