Director, Clinical Operational Excellence

Role Summary

Director, Clinical Operational Excellence defines and leads the long-term vision for Clinical Operations Excellence, ensuring alignment with corporate objectives and regulatory standards. You will partner with senior leaders in Clinical Development, Quality, and Regulatory to harmonize processes and elevate trial execution. You will design and deploy scalable, standardized processes, tools, and KPIs across clinical operations, and oversee performance dashboards, risk management, and trial health reporting. You will drive continuous improvement to increase trial efficiency, cost-effectiveness, and speed-to-market, and ensure inspection readiness with Quality Assurance.

Responsibilities

• Define and implement the long-term vision for Clinical Operations Excellence, ensuring alignment with corporate objectives and regulatory standards.
• Partner with senior leaders in Clinical Development, Quality, Regulatory, and other functions to harmonize processes and elevate trial execution.
• Lead the design and deployment of scalable, standardized processes, tools, and KPIs across clinical operations.
• Oversee operational performance dashboards, risk management frameworks, and trial health reporting to ensure proactive issue identification and resolution.
• Champion continuous improvement initiatives that enhance trial efficiency, cost-effectiveness, and speed-to-market.
• Partner with Quality Assurance to ensure inspection readiness and adherence to compliance frameworks.
• Develop and implement frameworks to ensure adherence to regulatory requirements and Good Clinical Practice (GCP) guidelines. Ensure adherence to global regulatory requirements, ICH-GCP, and company SOPs.
• Develop training programs and support change management initiatives to embed best practices.
• Drive continuous process improvements to enhance operational efficiency, quality, and effectiveness in clinical oversight.

Qualifications

• 10+ years of experience in the biotech/pharmaceutical industry with direct experience in project management within Clinical Operations
• Proven track record in process improvement, clinical trial execution, and operational strategy.
• Experience with planning, management, and oversight of activities and deliverables within Clinical Operations
• Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance
• Proven track record of managing multiple projects and/or programs concurrently
• Excellent analytical, problem-solving, and organizational skills.
• Strong communication and interpersonal skills with the ability to influence cross-functional stakeholders.
• Demonstrated ability to lead change and foster a culture of continuous improvement.