Senior Manager, Global Site Start Up Lead

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $134.4k - $219.2k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Develop and execute global site and country start-up strategies for complex clinical trials • Identify risks, dependencies, and mitigation plans • Lead site activation planning and forecasting activities to achieve study milestones and timelines • Partner with Clinical Operations, Regulatory Affairs, CROs, and other stakeholders to drive study start-up execution • Monitor and evaluate start-up metrics and use data and trends to improve performance and inform strategic decisions • Oversee regulatory document collection, submissions, site initiation readiness, and milestone tracking • Provide leadership and direction to CRO partners and internal teams for high-quality, compliant start-up delivery • Serve as the primary escalation point for site start-up challenges • Resolve issues proactively and drive cross-functional alignment • Manage and develop a team of Site Start-Up professionals through coaching, performance management, mentoring, and career development initiatives

🎯 Requirements

• Bachelor's degree and 8+ years of pharmaceutical, biotechnology, or clinical research industry experience • Extensive experience leading global clinical trial start-up activities, including country and site activation strategies • Strong knowledge of ICH-GCP guidelines, clinical trial regulations, and global study start-up processes • Demonstrated ability to lead cross-functional teams and influence stakeholders across a global organization • Proven experience managing vendors and CROs, including performance oversight and issue resolution • Excellent project management, communication, negotiation, and risk management skills • Previous direct line management experience with responsibility for staff development and performance management preferred • Experience supporting complex, high-profile, and global clinical development programs preferred • Strong analytical mindset with a data-driven approach to forecasting, metrics review, and operational decision-making preferred • Experience driving process improvements and operational excellence initiatives within Clinical Development preferred • Advanced understanding of country-specific regulatory and site activation requirements across multiple regions preferred • Ability to work primarily in a computer-based environment • Ability to travel domestically and internationally up to 25% as required • Ability to participate in meetings across multiple global time zones

🏖️ Benefits

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Medical, dental, vision, life, and disability insurance benefits • Paid time off • Family support benefits • Reasonable accommodation for applicants with known disabilities or chronic illnesses • Remote work model • Travel up to 25%