Senior Director of Clinical Operations

Job Summary

To lead the establishment of a centralized Clinical Operations Business Office, the remote Senior Director of Clinical Operations will manage inspection readiness, oversee vendor governance, and drive continuous improvement across clinical trial execution.

Key responsibilities

• Set the strategy for the Clinical Operations Business Office, defining operating models and performance measures
• Oversee vendor governance and site contracting, ensuring compliance and effective negotiation practices
• Lead the electronic trial master file governance strategy and maintain continuous inspection readiness across the clinical portfolio

Required qualifications

• BSc in a scientific, business, healthcare, or related discipline; advanced degree preferred
• 12+ years of experience in clinical operations or related functions within biotechnology or pharmaceutical organizations
• Expertise in clinical sourcing, vendor governance, and contract negotiation
• Experience with eTMF governance and risk-based quality management processes
• Proven track record of defining functional strategy and leading senior professionals in a collaborative environment