Director, Clinical Operations

Role Summary

This role provides strategic leadership to Clinical Trial Managers, driving high-quality trial execution through strong team development, vendor oversight, and continuous process improvement.

Responsibilities

• Lead, mentor, and develop the team of Clinical Trial Managers (CTMs), fostering a culture of accountability, collaboration, and professional growth.
• Provide strategic direction and operational oversight for clinical trial execution across multiple programs and indications.
• Ensure appropriate resource allocation, workload balance, and succession planning within the CTM team.

• Oversee the selection, management, and performance of clinical trial vendors, including CROs and key service providers.
• Establish clear vendor expectations, performance metrics, and escalation pathways.
• Partner with Procurement, Clinical Operations leadership, and GCP Quality representatives to optimize vendor governance processes.

• Drive ongoing process improvement initiatives within Clinical Operations to enhance efficiency, quality, and compliance.
• Ensure operational practices and systems support scalability and inspection readiness.
• Collaborate with GCP Quality representatives to incorporate lessons learned, audit findings, and regulatory updates into processes.
• Serve as a subject matter expert for GCP compliance, supporting internal training and continuous improvement.

• Lead inspection readiness activities across Clinical Operations, ensuring documentation, systems, and processes are maintained in an audit-ready state.
• Partner with GCP Quality representatives and cross-functional stakeholders to proactively identify risks and implement mitigation strategies.
• Provide leadership support during audits and regulatory inspections, representing Clinical Operations as needed.

Qualifications

• Bachelor‚Äôs degree in life sciences or related field; advanced degree preferred.
• 10+ years of clinical research experience with increasing responsibility, including 5+ years in clinical trial management or clinical operations leadership.
• Proven experience managing and developing clinical operations teams.
• Strong track record of vendor management and oversight of CROs and service providers.
• Expertise in ICH/GCP guidelines, clinical trial regulations, and inspection readiness best practices.
• Excellent leadership, organizational, and communication skills.
• Strategic thinker with strong operational execution.
• Collaborative leader with ability to influence across functions and at all organizational levels.
• High attention to detail with strong problem-solving and risk management skills.
• Committed to continuous improvement, innovation, and patient-focused research.

Compensation

The expected base salary range for this position is $176,659 to $229,427.

Compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days.