Associate Director, Clinical Trial Start-Up

Jazz Pharmaceuticals; Palo Alto (CA); On-site; USD 165,000 - 247,000; Full time

Job summary

Jazz Pharmaceuticals in the United States seeks an Associate Director, Study Start Up Strategy, to provide advanced expertise in global CTSU processes and lead cross-functional start-up efforts across trials. You will oversee country/site activation plans, leverage analytics and predictive data to optimize timelines, manage CROs, and drive continuous improvement while ensuring regulatory compliance.

The role requires 8–10 years in clinical research with 5+ years in start-up, a life sciences

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• 8–10 years in clinical research with 5+ years focused on start-up or site activation.
• Strong understanding of global regulatory requirements and IRB/EC processes.
• Experience leading cross-functional teams and managing CROs/vendors.
• Proficiency with SSU tools and assessment of new technologies (AI) in SSU space).

Responsibilities

• Lead or oversee development and execution of study-level start-up strategies and country/site activation plans.
• Develop site activation projections and input into study timelines from data-driven assessments.
• Serve as SME on global start-up pathways and guide internal teams and partners.
• Partner cross-functionally to align start-up activities with protocol requirements and governance.
• Oversee CROs/vendors and track KPIs, timelines, and risk management.
• Lead initiatives to improve start-up methodology, tools, and processes.
• Support audit readiness and regulatory submissions documentation.
• Represent SSU in industry discussions and governance meetings.

Skills

SSU expertise

Cross-functional leadership

Data-driven insights

CTMS experience

Veeva Vault

Regulatory knowledge

Leadership

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

CTMS

Veeva Vault

Document management

Job description

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

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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Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $164,800.00 - $247,200.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.