Executive Director – Global Site & Study Operations

Stellenbeschreibung:

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.