ICON plc
Vice President, Site Activation Project Management and Global Regulatory Oversight
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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.
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.
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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.
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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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Employment
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply.
ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live.
If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.
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