Associate Director, Clinical Trial Start-Up

🔥 13 hours ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $164.8k - $247.2k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• 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, predictive data, and emerging technologies • Serve as a Subject Matter Expert in global study, country, and site start-up pathways • Partner cross-functionally to deliver start-up insights and strategies informing country and site selection, timelines, and activation strategies • Track and analyze SSU performance metrics, identify trends and issues, and address and communicate risks • Leverage historical and predictive data, real-world evidence, and emerging technologies to optimize start-up strategies and activation processes • Oversee SSU team members, providing guidance, training, and performance feedback • Oversee CROs/vendors executing start-up activities, including performance tracking against KPIs and timelines • Lead or contribute to initiatives improving start-up methodology, quality, tools, and process efficiency • Support audit and inspection readiness by ensuring accurate and complete documentation of start-up activities and regulatory submissions • Participate in development and refinement of global SSU policies, SOPs, and training curricula • Represent SSU in industry discussions, cross-industry collaboration efforts, and internal governance meetings

🎯 Requirements

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

🏖️ Benefits

• Discretionary annual cash bonus or incentive compensation • Discretionary equity grants • Medical insurance • Dental insurance • Vision insurance • 401k retirement savings plan • Flexible paid vacation • 10% to 20% travel, US and International