Associate Director, Clinical Trial Start-Up

Essential Functions/Responsibilities

• Lead or provide oversight of development and execution of study-level start-up strategies, country/site activation plans, and risk mitigation approaches through SSU roles and/or CRO.
• Develop site activation projections and provide input into study timeline development through data-driven assessment of country requirements, historical timelines and leveraging predictive data and emerging technologies.
• Serve as a Subject Matter Expert (SME) in global study, country, and site start-up pathways, offering strategic guidance to internal teams and partners and in relevant industry discussions.
• Partner cross-functionally to deliver start-up insights and strategies that inform country and site selection, timelines, and country/site activation strategies, aligning these with protocol requirements at the indication, program, or study level through collaborative workstreams and representation on the Clinical Trial Working Group (CTWG) for assigned trials.
• Track and analyze SSU performance metrics, proactively identifying trends, issues at study, country, program level, working cross functionally to address and communicate risks.
• Leverage historical and predictive data, real-world evidence, and emerging technologies to optimize start-up strategies, mitigate operational risks, and enhance country and site activation processes.
• Oversee SSU team members, providing guidance, training, and performance feedback to support their development.
• Oversight of CROs/vendors executing start-up activities, including performance tracking against KPIs and timelines and provides support for governance activities.
• Lead or contribute to functional initiatives that improve start-up methodology, quality, tools, and process efficiency across programs, including the development and implementation of SSU policies, processes, and training.
• Support audit and inspection readiness by ensuring accurate and complete documentation of start-up activities and regulatory submissions.
• Participate in the development and refinement of global SSU policies, SOPs, and training curricula aligned with evolving regulatory and business needs.
• Represent SSU in relevant industry discussions, cross-industry collaboration efforts, and internal governance meetings as appropriate.

Required Knowledge, Skills, and Abilities

• Recognized as a subject matter expert in clinical site start-up with strong operational understanding of global regulatory requirements, IRB/EC processes, and site activation pathways.
• Proven ability to drive cross-functional decision-making through data-driven insights.
• Demonstrated success supporting or leading global clinical start-up strategy in both in-house and outsourced models, specifically oversight of CROs or vendors.
• Experience leveraging digital technologies to inform study planning and start-up optimization.
• Ability to analyze complex issues and apply strategic thinking to identify risk and resolve operational challenges across cross-functional settings.
• Strong leadership, collaboration, and communication skills, with the ability to influence cross-functional teams and external partners.
• Proficiency with CTMS, document management systems, and SSU technology platforms (e.g., Veeva Vault), with experience in assessment or utilization of AI in this SSU space preferred.
• Experience contributing to inspection readiness and continuous process improvement initiatives.
• 10% to 20% travel, US and International.

Required/Preferred Education and Licenses

• Bachelor’s degree in life sciences or related field required; advanced degree preferred.
• 8-10 years of experience in clinical research, with at least 5 years focused on clinical trial start up or site activation.