Vice President, Site Activation Project Management and Global Regulatory Over...
New
Based in United StatesFull-TimeVp
SalaryCompetitive base salary with performance-based incentives.
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Job Details
- Required Skills
- Project ManagementStakeholder managementChange Management
Requirements
- 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 in a CRO or similar environment.
- Proven success managing global clinical trial launches and complex programs across multiple regions.
- Significant experience leading 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.
- Ability to lead cross-functional teams spanning site selection, regulatory affairs, contracts, and clinical operations.
- Strong strategic thinking, change management, and operational improvement skills.
- Exceptional executive communication, stakeholder management, and relationship-building abilities.
- Willingness to travel domestically and internationally up to 25%.
Responsibilities
- Develop and execute global strategies for study start-up, site activation, and regulatory delivery.
- Lead and develop a global organization of site activation and regulatory professionals.
- Oversee harmonized operating models to ensure scalability and consistent execution across customer programs.
- Serve as an executive sponsor, coordinating activities across site selection, regulatory affairs, contracts, and clinical operations.
- Provide strategic oversight for global regulatory activities and submission processes.
- Partner with cross-functional executives to identify risks, remove operational barriers, and improve study timelines.
- Establish and monitor performance indicators, quality metrics, and operational dashboards.
- Act as a senior escalation point and strategic partner for sponsor relationships.
- Lead organizational transformation and process improvement initiatives.
- Foster an inclusive culture focused on leadership development and collaboration.
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