Director, Clinical Trial Start Up

Role Summary

The Director, Clinical Trial Start-Up is responsible for the strategic leadership and operational oversight of the Study Start-Up (SSU) process and staff. This role directs SSU planning, the development and optimization of end-to-end SSU processes and oversees the performance and development of SSU staff across multiple clinical programs. This role will ensure SSU operations align with corporate objectives, regulatory compliance, and industry best practices to accelerate country and site activation timelines and support clinical trial readiness globally.

Responsibilities

• Provide strategic leadership of the global SSU function, ensuring operational excellence across country and site start-up activities.
• Accountable for process that enables study-level and program-level start-up strategy development, partnering with Clinical Operations, Regulatory Affairs, CROs, and other stakeholders to lead planning for successful and timely country and site start-up.
• Lead activities that develop, implement, and continuously improve SSU policies, processes, SOPs, training and performance metrics to enhance efficiency, scalability, and compliance applying in-depth knowledge of the company, external environment and industry best practices.
• Lead and develop a high-performing SSU team, including resource management, hiring, training, & performance reviews.
• Using wide-ranging experience, serve as a Subject Matter Expert (SME) for complex trial start-up issues and lead creative risk mitigation and strategic decision-making to resolve operational challenges.
• Develop and implement effective knowledge management solutions for start-up insights to inform streamlined planning and efficient data utilization and reuse
• Align SSU activities with corporate goals, budgets, timelines, and quality standards.
• Accountable for functional level oversight of CROs or vendors involved in start-up execution, including governance, KPIs, and compliance.
• Support and prepare for regulatory inspections and audits related to start-up operations.
• Collaborate with cross-functional teams (e.g., Clinical Development, Regulatory, Site Budgets and Contracts, Legal) to ensure integrated and efficient trial start-up processes.
• Monitor and analyze department metrics and performance data, using insights to drive continuous improvement initiatives.
• Represent SSU leadership in executive meetings, governance boards, and strategic planning sessions.
• Represents Jazz in cross industry collaboration efforts and forums as well as regular review of relevant external landscape updates information via events, literature review or industry network participation

Skills

• Experience in the development and implementation of global clinical trial process and change management activities
• Advanced expertise in global clinical trial start-up strategy, regulatory country and site activation pathways landscapes, and operational clinical trial execution.
• Familiar with establishing KPIs and operational metrics for clinical trial start up execution quality across studies, utilizing insights to inform process improvements and executive reporting.
• Proven Cross functional leader, able to build effective partnerships with key functions including Clinical Operations, Clinical Development, Medical Affairs
• Demonstrated ability to lead and develop teams, manage resources, lead complex projects, and drive cross-functional decisions through data driven discussions.
• Demonstrated experience in functional oversight of CRO and vendor partnerships supporting SSU, including governance oversight, performance management, and contract and budget alignment.
• Proficiency in SSU knowledge management, CTMS Systems, and document management platforms (e.g., Veeva Vault) with some experience in assessment or utilization of AI LLM preferred
• Experience with inspection readiness and continuous process improvement initiatives.

Education

• Bachelor’s degree in life sciences or related field required; advanced degree preferred.
• 15+ years of experience in clinical research, with 5+ years in leadership roles within Site Start-Up or Clinical Operations.