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Vice President, Site Activation Project Management and Global Regulatory Oversight

ICON
Remote
Remote

About this role

About the Role

The Vice President, Site Activation Project Management and Global Regulatory Oversight at ICON provides strategic and operational leadership for ICON's global study start-up organization. You will ensure timely, compliant, and efficient initiation of clinical trials across diverse portfolios, leading a harmonized model for site activation and regulatory oversight and serving as the executive sponsor for study start-up delivery excellence. What You'll Do

  • Develop and implement comprehensive strategies for study start-up, site activation, and regulatory delivery that align with organizational goals, client expectations, and evolving industry requirements.

  • Lead a global organization of site activation and regulatory professionals to drive efficiency, collaboration, accountability, and high-quality project outcomes.

  • Oversee the harmonized FSA operating model supporting large pharma and biotech clients, ensuring consistency, scalability, and operational excellence across client portfolios.

  • Serve as the executive leader for sponsor-facing study start-up delivery, with FSA teams coordinating across Site Selection, Regulatory Affairs, Contracts, Site Activation, and other key functions.

  • Provide leadership and oversight of the Global Regulatory Partner team, ensuring strategic regulatory guidance, study-level oversight, and effective management of global submission activities.

  • Partner with Clinical Operations, Project Management, Business Development, and cross-functional leaders to proactively identify and resolve start-up challenges and risks.

  • Establish, monitor, and improve KPIs, cycle times, quality metrics, and operational metrics to drive continuous improvement and predictable delivery.

  • Build trusted relationships with sponsors and external stakeholders, acting as an executive escalation point and strategic advisor throughout start-up and activation activities.

  • Drive transformation, process harmonization, and innovation to enhance the customer experience and improve global study start-up performance.

  • Foster a culture of collaboration, inclusion, accountability, and talent development across geographically distributed teams. What We're Looking For

  • Bachelor's degree in a scientific, healthcare, life sciences, or related field; advanced degree preferred.

  • Extensive experience in clinical study start-up, site activation, and regulatory operations within a CRO environment, with a proven track record of leading successful global study launches.

  • Significant leadership experience managing large, geographically dispersed teams and developing high-performing leaders.

  • Demonstrated success overseeing sponsor-facing delivery organizations and building strategic partnerships with pharmaceutical and biotechnology clients.

  • Deep understanding of global regulatory requirements, submission processes, and study activation activities across multiple regions.

  • Proven ability to lead cross-functional organizations and influence outcomes across Site Selection, Regulatory Affairs, Contracts, Activation, Clinical Operations, and Project Management.

  • Strong strategic thinking, operational excellence, and change leadership with experience driving process improvement and organizational transformation.

  • Exceptional communication, executive presence, and relationship-management skills with the ability to engage internal and external stakeholders at all levels.

  • Commitment to fostering diversity, inclusion, collaboration, and continuous learning.

  • Preference for candidates in the United States, with consideration for Europe.

  • Ability to travel domestically and internationally up to 25%. Compensation & Benefits

ICON offers a competitive salary and a range of benefits designed to support well-being and work-life balance, including various annual leave entitlements, health insurance options, retirement planning, LifeWorks global Employee Assistance Programme, life assurance, flexible optional benefits (childcare vouchers, bike purchase schemes, gym memberships, travel passes, health assessments), and more. Visit our careers site to read more about ICON's benefits. ICON is committed to inclusion and belonging, providing an inclusive and accessible environment for all candidates.

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