Vice President, Site Activation Project Management and Global Regulatory Oversight

Vice President, Site Activation Project Management and Global Regulatory Oversight

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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.

What You Will Do

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%

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply