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Remote - United States
Source: Regeneron Pharmaceuticals careers · View original posting
From Regeneron Pharmaceuticals's posting. “We” and “our” refer to the employer.
Build Our Future Together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Global Site Start-Up Lead to join our Global Development team , supporting complex, high-profile clinical trials across our global portfolio. In this role, you will lead the strategic execution of site and country start-up activities, driving efficient study activation and operational excellence while ensuring compliance with regulatory requirements and industry standards.
Working closely with cross-functional partners, clinical operations teams, and CROs, you will play a critical role in accelerating study timelines, mitigating risks, and enabling the successful delivery of clinical development programs that bring innovative therapies to patients worldwide.
When & Where
Develop and execute global site and country start-up strategies for complex clinical trials, identifying risks, dependencies, and mitigation plans.
Lead site activation planning and forecasting activities to ensure study milestones and timelines are achieved.
Partner with Clinical Operations, Regulatory Affairs, CROs, and other stakeholders to drive efficient study start-up execution.
Monitor and evaluate start-up metrics, leveraging data and trends to improve performance and inform strategic decision-making.
Oversee site activation activities including regulatory document collection, submissions, site initiation readiness, and milestone tracking.
Provide leadership and direction to CRO partners and internal teams to ensure high-quality and compliant start-up delivery.
Serve as the primary escalation point for site start-up challenges, proactively resolving issues and driving cross-functional alignment.
Manage and develop a team of Site Start-Up professionals through coaching, performance management, mentoring, and career development initiatives.
This Role Requires
Must-Haves
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.
Compensation
$134,400.00 - $219,200.00
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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