Associate Director, Clinical Trial Start-Up

Jazz Pharmaceuticals; California, Northern (PA, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Jazz Pharmaceuticals seeks an Associate Director, Study Start Up Strategy to lead global SSU strategy across the portfolio. You will drive cross-functional collaboration with regulatory, quality, and operations, implement data-driven start-up plans, and oversee CRO/vendor performance to ensure timely country/site activation.

The role emphasizes strategic leadership, risk mitigation, and continuous process improvement, with significant global scope and travel.

Qualifications

• 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

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.

Skills

Subject matter expert

Cross-functional leadership

Data-driven decision making

Strategic thinking

Stakeholder collaboration

Leadership

Education

Bachelors degree in life sciences

Advanced degree preferred

Tools

CTMS

Veeva Vault

Document management systems

SSU technology platforms

Job description

Brief Description:

The Associate Director, Study Start Up Strategy, provides advanced expertise in clinical trial start-up processes, responsible for developing and overseeing global clinical trial start-up (CTSU) strategies across the Jazz clinical trial portfolio. This role combines operational leadership with strong cross-functional collaboration, CRO oversight, and continuous improvement, ensuring compliance with global regulatory and quality standards.

This individual leverages analytics and data-driven insights—both historical and predictive—to strategically inform country and site activation plans, optimize protocol implementation for start-up efficiency, and mitigate operational risks. This position is critical to ensure efficient, data-driven, and scalable clinical trial planning strategies for rapid country and site activation.

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 [User's previous response
• 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.

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