Vice President, Site Activation Project Management and Global Regulatory Oversight

Vice President, Site Activation Project Management and Global Regulatory Oversight

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients, and suppliers.

As the Vice President, Site Activation Project Management and Global Regulatory Oversight at ICON, you will provide strategic and operational leadership for our global study start-up organization, ensuring the timely, compliant, and efficient initiation of clinical trials across diverse customer portfolios.

Operating within a harmonized model supporting both large pharmaceutical and biotech clients, you will lead teams responsible for site activation and regulatory oversight while serving as a key executive sponsor for study start-up delivery excellence. You will drive consistent execution, operational innovation, and client satisfaction across all study start-up activities.

Your leadership will shape global site activation and regulatory strategy, build organizational capability, and ensure delivery excellence at scale.

Key Responsibilities:

• Developing and implementing comprehensive strategies for study start-up, site activation, and regulatory delivery that align with organizational goals, client expectations, and evolving industry requirements.
• Leading a global organization of site activation and regulatory professionals to drive efficiency, collaboration, accountability, and high-quality project outcomes.
• Overseeing the harmonized FSA operating model supporting both large pharma and biotech customers, ensuring consistency, scalability, and operational excellence across client portfolios.
• Serving as the executive leader for sponsor-facing study start-up delivery, with FSA teams acting as the primary client interface coordinating execution across Site Selection, Regulatory Affairs, Contracts, Site Activation, and other key functional areas.
• Providing leadership and oversight of the Global Regulatory Partner team, ensuring strategic regulatory guidance, study-level regulatory oversight, and effective management of global submission activities.
• Partnering closely with Clinical Operations, Project Management, Business Development, and other cross-functional leaders to proactively identify and resolve study start-up challenges and risks.
• Establishing, monitoring, and improving key performance indicators, cycle times, quality measures, and operational metrics to drive continuous improvement and predictable delivery.
• Building and maintaining trusted relationships with sponsors and external stakeholders, serving as an executive escalation point and strategic advisor throughout study start-up and activation activities.
• Driving organizational transformation, process harmonization, and innovation to enhance the customer experience and improve study start-up performance globally.
• Fostering a culture of collaboration, inclusion, accountability, and talent development across geographically distributed teams.

Your Profile:

• 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 Contract Research Organization (CRO) environment, with a proven track record of leading successful study launches across global programs.
• Significant leadership experience managing large, geographically dispersed teams and developing high-performing leaders.
• Demonstrated success overseeing sponsor-facing delivery organizations and building strong 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 functions.
• Strong strategic thinking, operational excellence, and change leadership capabilities with experience driving process improvement and organizational transformation.
• Exceptional communication, executive presence, and relationship-management skills, with the ability to effectively engage internal and external stakeholders at all levels.
• Commitment to fostering diversity, inclusion, collaboration, and continuous learning within teams and across the organization.
• Prefer candidates who live in the US, but candidates in Europe will also be considered
• Able to travel domestically and internationally up to 25%