Overview Executive role leading regional Study & Site Operations across the Americas to ensure timely, high-quality, compliant trial delivery. You will set enterprise-wide strategy, oversee leaders, and influence cross-functional partners to optimize site engagement and monitoring. You will drive innovation, digital solutions, and resource strategies while maintaining audit-ready operations. This is a mission-driven senior role that shapes regional execution within a global portfolio.
Compensation / Benefits- Competitive compensation
- Total Rewards Plan including benefits for dependents
- Stock-based long-term incentives
- Discretionary annual bonus or incentive plan
- Generous retirement/savings contributions
- Flexible work models where possible
Responsibilities- Oversee Americas region including US, Canada, and LATAM; provide portfolio-level strategic leadership and cross-functional influence
- Lead initiation, management, quality, and completion of Phase I-IV trials in region with ICH-GCP/regulatory compliance
- Shape site-monitoring approaches and resource strategies; ensure appropriate use of centralized, on-site, and remote monitoring
- Represent region in enterprise forums to inform portfolio planning and study scheduling; coach teams on mitigation strategies
- Build and develop high-performing Country/Hub heads; foster accountability, innovation, and operational excellence
- Champion continuous improvement in start-up approaches; embed digital solutions and harmonized processes across global portfolio
- Ensure regional delivery aligns with global strategies; optimize allocation and use of internal and augmented resources
- Maintain oversight of regional trial portfolio from start-up to closeout; ensure inspection readiness and timely audits
- Lead capability building and talent development; promote inclusive, patient-focused culture across distributed teams
- Engage with cross-functional capabilities to drive site engagement, performance, and patient recruitment/retention
- Act as regional escalation point for risks and issues; drive timely resolution and visibility
- Develop and sustain CRA monitoring organization with appropriate resourcing and standards
- Implement evolving site-engagement models and cross-functional collaboration to improve site experience and performance
- Represent GSSO in global governance bodies with authority to influence timelines and resources
- Drive regional and global clinical operations transformation initiatives; foster knowledge-sharing and best practice adoption
- Lead stakeholder engagement with Clinical Development, Regulatory, Safety, Biometrics, Data Management, Quality, and others
- Maintain accountability for regional trial delivery, including budget and resource allocation
- Coach teams to manage challenges, escalation, and problem-solving
- Ensure structure and processes enable rapid, compliant trial execution across geographies
Key requirements- Doctorate, 6+ years of global site study experience OR Master, 10+ years OR Bachelor, 12+ years with 6+ years of managerial experience
- Bachelor's degree in life sciences, pharmacy, nursing, medicine, or related discipline; advanced degree preferred
- 15+ years of progressive pharma/biotech/CRO/clinical research experience
- Extensive clinical operations and study management across multiple phases
- Leadership experience managing managers and geographically distributed teams
- Experience overseeing complex global/regional clinical trial portfolios
- Experience with CRO/vendor governance, outsourcing, budget management, and resource planning
- Strong knowledge of ICH-GCP, regulatory requirements, and regulatory inspections support
- Experience working with CROs, central labs, imaging vendors, and other clinical vendors
- Understanding of local regulatory requirements for clinical trials across relevant geographies
- Demonstrated ability to lead organizational change, drive performance, and cross-functional collaboration
- Excellent communication and influence skills across senior leadership
- Ability to manage budgets, resources, and performance metrics across global priorities
- Cross-functional collaboration
- Strategic leadership
- Change management
- ICH-GCP expertise
- Global/regional clinical trial management
- Portfolio budgeting and resource planning
