Vice President, Site Activation Project Management and Global Regulatory Oversight

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Vice President, Site Activation Project Management and Global Regulatory Oversight based in United States.

This executive leadership role is responsible for shaping global clinical trial start-up strategies and ensuring the successful activation of studies across diverse healthcare portfolios.
The position oversees large-scale teams focused on site activation, regulatory operations, and operational excellence.
It plays a critical role in improving delivery timelines, quality standards, and client satisfaction through innovative and harmonized processes.
The successful candidate will act as a strategic advisor to internal teams, sponsors, and external stakeholders throughout the study lifecycle.
This role requires strong leadership capabilities, deep clinical research expertise, and the ability to drive transformation across a global organization.
Working in a collaborative and fast-paced environment, the leader will influence the future of clinical trial execution worldwide.

The Vice President will provide strategic direction and operational oversight for global study start-up activities, ensuring efficient, compliant, and predictable clinical trial activation. This role will lead teams, optimize processes, strengthen client partnerships, and drive continuous improvement across site activation and regulatory functions.

• Develop and execute global strategies for study start-up, site activation, and regulatory delivery aligned with business objectives, customer expectations, and industry standards.
• Lead and develop a global organization of site activation and regulatory professionals, promoting accountability, collaboration, and operational excellence.
• Oversee harmonized operating models supporting pharmaceutical and biotechnology customers, ensuring scalability and consistent execution across programs.
• Serve as an executive sponsor for study start-up delivery, coordinating activities across site selection, regulatory affairs, contracts, activation, and clinical operations teams.
• Provide leadership and strategic oversight for global regulatory activities, including submission processes and study-level regulatory guidance.
• Partner with cross-functional executives to identify risks, remove operational barriers, and improve study timelines and outcomes.
• Establish and monitor performance indicators, quality metrics, cycle times, and operational dashboards to drive measurable improvements.
• Build trusted relationships with sponsors and external stakeholders, acting as a senior escalation point and strategic partner.
• Lead organizational transformation initiatives, process improvements, and innovation efforts to enhance study start-up performance.
• Foster an inclusive culture focused on collaboration, leadership development, and continuous learning across distributed teams.

Requirements:

The ideal candidate brings extensive experience in clinical research operations, global study start-up leadership, and regulatory oversight within a complex healthcare environment. They combine strategic vision with operational expertise and possess the ability to influence senior stakeholders while managing large international teams.

• Bachelor’s degree in a scientific, healthcare, life sciences, or related discipline; advanced degree preferred.
• Extensive experience leading clinical study start-up, site activation, and regulatory operations within a Contract Research Organization (CRO) or similar environment.
• Proven success managing global clinical trial launches and delivering complex programs across multiple regions.
• Significant leadership experience overseeing geographically distributed teams and developing high-performing organizations.
• Strong background in sponsor-facing operations and building strategic partnerships with pharmaceutical and biotechnology clients.
• Deep knowledge of global regulatory requirements, submission processes, and clinical trial activation activities.
• Demonstrated ability to lead cross-functional teams spanning site selection, regulatory affairs, contracts, activation, clinical operations, and project management.
• Strong strategic thinking, change management, operational improvement, and transformation leadership skills.
• Exceptional executive communication, stakeholder management, and relationship-building abilities.
• Commitment to fostering diversity, inclusion, collaboration, and professional development.
• Willingness to travel domestically and internationally up to 25%.

Benefits:

• Competitive base salary with performance-based incentives.
• Comprehensive healthcare benefits, including medical, dental, and vision coverage where applicable.
• Retirement and pension plan options.
• Life insurance and disability coverage.
• Employee assistance programs and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Opportunity to lead global initiatives with significant impact on clinical research delivery.
• Flexible remote work environment with opportunities to collaborate internationally.