Director Site Operations – Europe

• Provide strategic and operational leadership for clinical trial execution across assigned European countries
• Lead, coach, and develop Clinical Country & Site Leads and assigned country/site operations resources
• Maintain relationships with investigators, research sites, healthcare institutions, and affiliate leadership teams
• Provide country, site, and operational intelligence for feasibility, protocol implementation, patient recruitment, country selection, site strategy, enrollment forecasting, and study execution
• Support country selection, site selection, enrollment planning, and portfolio decision-making
• Partner with clinical monitoring, site management, CRO/FSP, and cross-functional teams on trial oversight, escalation, quality, and execution standards
• Support implementation, governance, and continuous improvement of the CSO operating model, including IFM/SCOUT
• Represent CSO in global and regional initiatives involving protocol optimization, investigator engagement, risk-based quality, operational excellence, and transformation
• Support resource/workforce planning, performance tracking, annual objectives, and budget planning
• Lead a scope of approximately 5–8 direct reports and 15–25 indirect or matrixed resources

• Bachelor's Degree required; advanced degree preferred
• 12+ years of experience in clinical development or clinical operations, including significant experience in country-facing and site-facing operational roles
• Experience leading clinical operations activities across multiple countries or a sub-regional cluster required
• Experience working with global study teams, affiliate organizations, Medical, Development, Quality, monitoring teams, CRO/FSP partners, and external stakeholders expected
• Demonstrated experience managing people and/or matrix teams, with a strong track record of leadership, coaching, talent development, performance management, and operational delivery required
• Deep knowledge of global clinical development and clinical trial operations, including country and site operations, study execution, sponsor oversight, and site engagement
• Strong understanding of GCP, ICH guidelines, clinical trial regulations, and regulatory guidance pertinent to clinical trial conduct in assigned regions
• Proven ability to translate country, site, investigator, and affiliate insights into practical operational strategies
• Strong stakeholder management and influencing skills, including experience communicating with senior leaders and cross-functional teams
• Demonstrated people leadership skills, including coaching, talent development, performance management, and leading through change
• Ability to support financial/resource planning and operational performance oversight within an assigned sub-region

Demonstrates extensive experience in clinical trial operations and development, with a strong focus on leadership, stakeholder management, and operational excellence across multiple countries. Proven ability to implement strategic initiatives and optimize clinical processes while managing diverse teams and resources.

• Clinical Trial Operations
• Stakeholder Management
• Leadership and Coaching
• GCP and ICH Guidelines
• Operational Performance Oversight

• Clinical Development
• Protocol Implementation
• Patient Recruitment
• Enrollment Forecasting
• Site Strategy
• Country Selection
• Feasibility Assessment
• Performance Management
• Operational Delivery
• Regulatory Compliance

• Influencing Skills
• Team Development
• Communication Skills
• Change Management
• Relationship Management

• Clinical Trials
• Clinical Operations
• Country-Facing Roles
• Site Engagement
• Operational Excellence

• CSO Operating Model
• IFM/SCOUT
• CRO/FSP Partnerships
• Global Study Teams