Associate Director, Clinical Trial Start-Up

Initial Therapeutics, Inc.; Deutschland; Remote; EUR 142.000 - 213.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision insurance

401k retirement savings plan

Flexible paid vacation

Zusammenfassung

Jazz Pharmaceuticals, Inc. in the United States seeks an Associate Director, Study Start Up Strategy to lead global SSU initiatives. You will drive cross-functional collaboration, oversee CROs, and align activities with regulatory and quality standards to enable rapid country and site activation.

You will leverage analytics and data-driven insights to inform start-up planning, optimize timelines, and mitigate operational risks across trials and regions. Travel up to 20% may be required.

Qualifikationen

• Subject matter expert in clinical site start-up and regulatory processes.
• Proven ability to drive cross-functional decisions with data-driven insights.
• Experience leading global start-up strategy with CRO oversight (in-house or outsourced).
• Experience leveraging digital technologies to inform study planning and start-up optimization.
• Willingness to travel 10–20% domestically and internationally.

Aufgaben

• Lead or oversee development and execution of study-level start-up strategies and CRO oversight.
• Develop site activation projections and input study timelines using data-driven insights.
• Serve as SME in global start-up pathways and provide strategic guidance to internal teams.
• Partner cross-functionally to deliver start-up insights aligned with protocol requirements.
• Track SSU performance metrics and communicate risks to leadership.
• Oversee CROs/vendors and governance activities for start-up programs.
• Contribute to SSU policy development and training curricula.

Kenntnisse

Cross-functional leadership

Data-driven decisions

Strategic thinking

Leadership

Ausbildung

Bachelor's degree life sciences

Advanced degree preferred

Tools

CTMS

Veeva Vault

DMS

AI in SSU

Jobbeschreibung

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate totransform the lives of patients and their families. We are dedicated to developinglife-changing medicines for people with serious diseases — often with limited or notherapeutic options. We have a diverse portfolio of marketed medicines, including leadingtherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.Our patient-focused and science-driven approach powers pioneering research and developmentadvancements across our robust pipeline of innovative therapeutics in oncology andneuroscience. Jazz is headquartered in Dublin, Ireland with research and developmentlaboratories, manufacturing facilities and employees in multiple countries committed toserving 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.

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.

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.