Executive Director – Global Site & Study Operations

• Provide regional Study & Site Operations leadership across the Americas clinical trial portfolio
• Set enterprise-level strategic direction and provide operational oversight, people leadership, and cross-functional influence
• Lead regional and country/hub leaders and represent the region in global governance and portfolio decision-making forums
• Oversee initiation, management, quality, and completion of Phase I-IV clinical trials across the region
• Guide modern site-monitoring approaches and associated resource strategies
• Provide insights informing portfolio, program, and study-planning decisions
• Build and develop a high-performing Country/Hub head team
• Champion innovation and continuous improvement in study start-up approaches, digital solutions, predictive analytics, and harmonized ways of working
• Implement the Regional Study & Site Operations strategy and allocate study resources according to global priorities
• Optimize deployment of internal and staff-augmented resources across clinical programs
• Provide executive oversight of high-risk or strategically important clinical programs
• Act as the GSSO escalation point for study risks and issues and guide mitigation strategies and scenario planning
• Build and sustain a CRA monitoring organization
• Ensure appropriate use of centralized, on-site, and remote monitoring, targeted SDR/SDV, and risk/quality indicators
• Strengthen relationships with clinical research sites and improve site experience and performance
• Make decisions on regional study and site operations, resource allocation, budget utilization, and vendor performance
• Oversee the regional clinical trial portfolio from study start-up through enrollment, execution, database lock, and closeout
• Ensure inspection readiness throughout the clinical trial lifecycle and follow through to audits and inspections
• Represent GSSO and/or the region in global governance bodies
• Lead, coach, and develop regional and country Study & Site Operations leaders
• Manage performance, succession planning, leadership bench development, and organizational capability building
• Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams
• Lead organizational change and adoption of new operating models, technologies, monitoring approaches, and clinical development practices
• Identify process simplification and productivity opportunities using data and performance insights
• Lead or sponsor regional and global clinical operations transformation initiatives
• Partner with Clinical Development, Operations, Regulatory, and regional leaders to align study start-up strategy and resources
• Promote GSSO as a strategic enabler of faster and more predictable clinical trial execution

Requirements

• Doctorate degree & 6 years of global site study experiences OR Master’s degree & 10 years of global site study experiences OR Bachelor’s degree & 12 years of global site study experiences
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Bachelor’s degree in life sciences, pharmacy, nursing, medicine, or a related discipline required; advanced degree preferred
• 15+ years of progressive experience in pharmaceutical, biotechnology, CRO, or clinical research organizations
• Extensive clinical operations and study management experience across multiple phases of clinical development
• Significant leadership experience managing managers and/or large, geographically distributed clinical operations organizations, inclusive of a monitoring organization
• Demonstrated experience overseeing complex global or regional clinical trial portfolios
• Demonstrated experience with CRO/vendor governance, outsourcing models, budget management, and resource planning
• Track record of leading organizational change and improving clinical operations performance
• Strong knowledge of ICH-GCP, clinical development processes, and applicable regulatory requirements
• Experience supporting regulatory inspections and clinical quality management
• Experience working for or overseeing clinical research vendors (CROs, central laboratories, imaging vendors, etc.)
• Experience managing clinical operations across the relevant geography/region, including strong understanding of local regulatory requirements around clinical trials
• Ability to navigate cross-geographic and cultural dynamics and lead efficient global teams
• Demonstrated ability to motivate geographically dispersed teams inclusively and drive strategy and execution
• Experience delivering portfolio/cross-study budgets, timelines, and performance metrics
• Experience assessing internal capabilities and leading continuous improvement initiatives
• Experience leading organizations through cross-functional change initiatives
• Exceptional communication and influence skills
• Ability to build partnerships with Clinical Development, Medical, Regulatory Affairs, Safety, Biometrics, Data Management, Clinical Supply, Quality, and other functions
• Ability to communicate portfolio performance, risks, and strategic recommendations clearly to senior leadership

Core Competencies

Demonstrates extensive experience in clinical operations and study management across multiple phases of clinical development, with a strong focus on leadership, resource allocation, and regulatory compliance. Proven ability to drive organizational change and improve clinical operations performance while fostering a high-performing, inclusive culture.

Highest-signal resume keywords

• Clinical Operations Management
• Leadership Experience
• Regulatory Compliance Knowledge
• CRO/Vendor Governance
• Clinical Trial Portfolio Oversight

ATS Optimization Keywords

Hard Skills

• Clinical Trial Management
• Study Management
• Budget Management
• Resource Planning
• ICH-GCP Knowledge
• Regulatory Inspection Support
• Performance Metrics Delivery
• Continuous Improvement Initiatives
• Cross-Functional Change Leadership
• Data Management

Soft Skills

• Exceptional Communication
• Influence Skills
• Team Motivation
• Cultural Navigation
• Partnership Building

Industry Keywords

• Pharmaceutical
• Biotechnology
• CRO
• Clinical Research
• Life Sciences
• Clinical Development Processes
• Global Governance
• Study Start-Up Strategy
• Monitoring Approaches
• Clinical Quality Management