Senior Director, Regional Clinical Study Management

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Regional Clinical Study Management based in Canada. This senior leadership role oversees regional clinical study management across a portfolio of clinical trials, driving delivery from feasibility through closeout. The position provides strategic direction, mentorship, and operational leadership to clinical study managers and regional clinical operations teams. It combines responsibility for timelines, quality, budgets, resources, and inspection readiness with a strong focus on cross-functional collaboration. The role works closely with global study leadership, country teams, vendors, and other stakeholders to ensure regional execution aligns with broader portfolio objectives. It also contributes to operational strategy, process improvement, and the development of effective tools, work instructions, and SOPs. This is an opportunity to influence clinical development at scale while building high-performing teams and strengthening regional capabilities.

Provide inspirational leadership, coaching, mentorship, and performance feedback to regional clinical study managers and clinical operations professionals across different levels of experience. Lead regional delivery for assigned clinical studies or portfolios, ensuring milestones, quality standards, budgets, and inspection-readiness expectations are achieved throughout the study lifecycle. Oversee study planning and execution from feasibility and country allocation through site selection, start-up, recruitment, data collection, closeout, and, when required, Clinical Study Report activities. Optimize regional feasibility, recruitment, country allocation, site selection, study timelines, data-entry performance, query resolution, and other operational metrics in collaboration with global and regional stakeholders. Act as a regional escalation point for complex operational issues, proactively identifying risks and coordinating effective resolutions with country heads, functional leaders, sites, vendors, and other partners. Establish and reinforce regional quality expectations, ensuring compliance with protocols, SOPs, ICH/GCP standards, and applicable regulations, while maintaining continuous inspection readiness. Drive cross-functional collaboration and knowledge sharing, bringing together different perspectives and promoting the adoption of regional best practices and lessons learned. Contribute to the development and optimization of regional work instructions, SOPs, tools, and processes that improve efficiency, consistency, and study execution. Partner with sourcing and clinical business operations teams on regional vendor strategies, investigator fees, site payments, patient travel reimbursement, and other operational efficiency initiatives. Forecast regional resource requirements, develop contingency plans, optimize resource allocation across the study lifecycle, and contribute to headcount, operating plans, and budget decisions. Interview, manage, and evaluate regional clinical study managers while supporting career development, competency building, succession planning, and customized coaching and mentoring. Communicate portfolio progress, regional priorities, risks, and resource needs clearly to senior management and global study leadership. Requirements Bachelor's degree in a scientific or healthcare discipline, with 12+ years of progressive experience in clinical operations within biotechnology, pharmaceutical, or CRO environments. A master's degree in a scientific or healthcare discipline is preferred, with 8+ years of progressive clinical operations experience considered in combination with the advanced degree. Proven clinical research experience, including team leadership responsibilities within clinical functions and experience managing or contributing to multiple clinical studies. Strong understanding of clinical trial planning, feasibility, start-up, recruitment, site management, data collection, closeout, quality management, and inspection readiness. Demonstrated ability to lead regional or cross-functional clinical operations teams and influence stakeholders across different functions and geographies. Strong knowledge of clinical research quality standards, including ICH/GCP, study protocols, SOPs, and applicable regulatory requirements. Experience with resource planning, financial and budget considerations, vendor management, operational metrics, and workload prioritization. Excellent coaching, mentoring, people-management, communication, negotiation, decision-making, and escalation-management skills. Strategic and analytical mindset with the ability to translate portfolio objectives into practical regional execution strategies. Strong organizational skills, initiative, adaptability, continuous-learning mindset, and ability to operate effectively in a changing environment. Proficiency with Microsoft Office and project-planning applications. Willingness to travel as required by business needs. Benefits Senior leadership opportunity with responsibility for regional clinical study delivery and portfolio execution. Opportunity to influence clinical development strategies across multiple studies, therapeutic areas, and regional operations. Leadership and people-development responsibilities, including coaching, mentoring, performance management, and capability building. Exposure to global clinical operations, cross-functional collaboration, external partners, and senior stakeholders. Scope to improve clinical trial quality, efficiency, inspection readiness, resource utilization, and operational processes. Opportunity to contribute to regional tools, SOPs, work instructions, best practices, and continuous-improvement initiatives. Full-time position based remotely in Canada. Travel opportunities as required by business needs. Equal opportunity work environment focused on qualifications, merit, collaboration, inclusion, continuous learning, and professional development.

laptop-ats-crawler v3