Executive Director – Global Site & Study Operations

This is a fully remote position, open to applicants in California.

📋 Description

• Provide leadership for Study & Site Operations across the clinical trial portfolio in the Americas.

• Establish enterprise-level strategic direction and ensure operational oversight, including people leadership and cross-functional influence.

• Lead regional and country/hub leaders, representing the region in global governance and decision-making forums for the portfolio.

• Oversee the initiation, management, quality, and completion of Phase I-IV clinical trials throughout the region.

• Guide modern site-monitoring methodologies and associated resource strategies.

• Deliver insights that inform decisions related to portfolio, program, and study planning.

• Build and nurture a high-performing team of Country/Hub heads.

• Advocate for innovation and continuous improvement in study start-up methodologies, digital solutions, predictive analytics, and standardized operational practices.

• Implement the Regional Study & Site Operations strategy and allocate study resources according to global priorities.

• Optimize the deployment of internal and staff-augmented resources across clinical programs.

• Provide executive oversight for high-risk or strategically significant clinical programs.

• Serve as the escalation point for study risks and issues, guiding mitigation strategies and scenario planning.

• Establish and maintain a CRA monitoring organization.

• Ensure effective use of centralized, on-site, and remote monitoring, targeted SDR/SDV, and risk/quality indicators.

• Strengthen relationships with clinical research sites to enhance site experience and performance.

• Make decisions regarding regional study and site operations, including 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 at all stages of the clinical trial lifecycle and manage audits and inspections.

• Represent GSSO and/or the region in global governance bodies.

• Lead, mentor, and develop regional and country Study & Site Operations leaders.

• Manage performance, succession planning, leadership bench development, and enhance organizational capabilities.

• Cultivate a high-performing, inclusive, accountable, and patient-focused culture across geographically dispersed teams.

• Drive organizational change and the adoption of new operating models, technologies, monitoring strategies, and clinical development practices.

• Identify opportunities for process simplification and productivity enhancements through data and performance insights.

• Lead or sponsor initiatives for regional and global clinical operations transformation.

• Collaborate with Clinical Development, Operations, Regulatory, and regional leaders to align study start-up strategy and resources.

• Promote GSSO as a strategic enabler for expedited and more predictable clinical trial execution.

⛳️ Requirements

• Doctorate degree with 6 years of global site study experience, OR Master’s degree with 10 years of global site study experience, OR Bachelor’s degree with 12 years of global site study experience.

• At least 6 years of managerial experience directly managing personnel and/or leadership experience in directing teams, projects, programs, or resource allocation.

• Bachelor’s degree in life sciences, pharmacy, nursing, medicine, or a related field required; advanced degree preferred.

• Over 15 years of progressive experience in pharmaceutical, biotechnology, CRO, or clinical research organizations.

• Extensive experience in clinical operations and study management across various phases of clinical development.

• Significant leadership experience in managing managers and/or large, geographically distributed clinical operations teams, including monitoring organizations.

• Proven experience overseeing complex global or regional clinical trial portfolios.

• Experienced in CRO/vendor governance, outsourcing models, budget management, and resource planning.

• Track record of leading organizational change and enhancing clinical operations performance.

• Strong knowledge of ICH-GCP, clinical development processes, and relevant regulatory requirements.

• Experience supporting regulatory inspections and managing clinical quality.

• Familiarity with managing clinical research vendors (CROs, central laboratories, imaging vendors, etc.).

• Experience overseeing clinical operations in the relevant geography/region, with a solid understanding of local regulatory requirements for clinical trials.

• Ability to navigate cross-geographic and cultural dynamics while leading efficient global teams.

• Demonstrated capability to motivate geographically dispersed teams inclusively and drive strategy and execution.

• Experience delivering portfolio/cross-study budgets, timelines, and performance metrics.

• Skilled in assessing internal capabilities and leading continuous improvement initiatives.

• Proven experience guiding organizations through cross-functional change initiatives.

• Exceptional communication and influencing skills.

• Ability to forge partnerships with Clinical Development, Medical, Regulatory Affairs, Safety, Biometrics, Data Management, Clinical Supply, Quality, and other functions.

• Capacity to clearly communicate portfolio performance, risks, and strategic recommendations to senior leadership.

🏝️ Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Bi-annual company-wide shutdowns.

• Flexible work models where possible.

• Career development opportunities.

• Financial plans with opportunities to save for retirement or other goals.

• Work/life balance.