Executive Director, Clinical Development Operations Excellence and Compliance

Role Summary

The Executive Director, Clinical Development Operations Excellence and Compliance is a senior operational leader responsible for elevating the efficiency, quality, and compliance of clinical development operations execution. This role focuses on optimizing operational performance, embedding compliance by design, and ensuring global consistency in processes, systems, and governance frameworks across Clinical Development Operations and Clinical Development. This role will drive operational excellence, department risk mitigation, and continuous process improvement to ensure clinical programs are delivered with speed, quality, and regulatory integrity.

Responsibilities

• Partner with functional leaders to refine and optimize processes that elevate operational excellence and compliance across clinical trials, ensuring efficiency, consistency, and high-quality delivery.
• Establish and maintain harmonized, scalable processes and other solutions that improve executional quality and cycle time.
• Integrate regulatory and GCP requirements into operational practices to ensure proactive compliance and inspection readiness.
• Identify, prioritize, and lead initiatives that strengthen operational capability and organizational learning across clinical development operations.
• Collaborate with Clinical Development, Regulatory, Quality, and other applicable functions to align processes, mitigate operational risk, and support portfolio execution.
• Build/connect interface between SOP/process owners and functional leaders across Clinical Development Operations and Clinical Development as needed.
• Champion digital innovation, process simplification, and change management to modernize how clinical trials are delivered.
• Participate in governance committees related to operational excellence, clinical compliance, and risk management.
• Oversee internal audit readiness for Clinical Development Operations and support inspection management across global trials; support Clinical Study Teams with proactive risk mitigation and CAPA implementation as needed.
• Implement and lead an oversight and monitoring strategy to ensure consistent visibility into clinical execution quality, operational risk, and compliance performance across programs.
• Establish and lead a Clinical Development Operations Compliance Committee with managers and key study leads to review study quality, deviations, and regulatory compliance.

Qualifications

• Degree in Life Sciences, or a related field with 18+ years of experience in Clinical Development Operations or Clinical Operations, with at least 10 years in a senior operational or compliance leadership role.
• Deep understanding of global clinical research regulations (ICH-GCP, FDA, EMA, PMDA, etc.).
• Proven experience driving operational excellence and quality improvement initiatives in a complex, matrixed environment.
• Strong track record in inspection readiness, audit management, and remediation planning.
• Exceptional leadership, communication, and stakeholder management skills.
• Demonstrated ability to influence at the executive level and drive cross-functional alignment.

Location

Bedford, MA (hybrid; minimum two days on-site per week).

Travel

Approximately 25% travel.