Director, Country Operations Management

Location: Boston, Seaport 

Hybrid: 60% onsite  

The Director, Country Operations Management (DCOM) is a member of the local study delivery leadership team accountable for execution of interventional Phase 2 and 3 clinical trials within an assigned Therapy Area. This role is fully accountable for delivering all operational trial milestones—on time, with quality, and in compliance with ICH-GCP, SOPs, and US regulations. 

This role combines strategic project leadership with direct line management of a team of 8–10, ensuring optimized resource planning, cross-functional collaboration, and high team performance across complex clinical programs. 

This role offers the opportunity to lead impactful clinical programs while developing and empowering a team of clinical professionals. The DCOM plays a critical role in local study delivery , ensuring excellence in both people leadership and operational delivery. 

Key Responsibilities 

People Leadership & Team Development 

• Lead, manage, and develop a high-performing team of 8–10 direct reports, including local study project managers and clinical study administrators 

• Drive performance management, training, coaching, and career development aligned with business needs and individual development goals. 

• Manage workload allocation, resource optimization, and team succession planning in partnership with senior leadership and HR. 

• Provide input on compensation, bonus proposals, and promotions in collaboration with HR and the US Head of County Operations.  

End-to-End Study Oversight 

• Oversee the execution of Phase 2 & 3 interventional studies across site feasibility, start-up, recruitment, maintenance and close-out. 

• Ensure trial milestones and deliverables are achieved with high quality and within agreed timelines. 

• Robust oversight of site performance, study documentation, eTMF completeness, and regulatory compliance. 

• Project Management & Operational Delivery 

• Monitor key performance indicators (KPIs) and operational metrics across assigned TA to ensure quality and consistency. 

• Identify and mitigate operational risks, issues, and roadblocks in collaboration with global study teams and local partners. 

• Drive process improvements, standardization, and adoption of country-level best practices. 

• Lead transformation and change initiatives to strengthen the local Clinical Operations Management (COM) function. 

Stakeholder & Vendor Engagement 

• Collaborate cross-functionally with local Medical Affairs, Regulatory, Legal, Development Quality, and other internal partners. 

• Manage external vendor performance, including CROs and FSPs, ensuring alignment with clinical objectives and standards. 

• Maintain effective communication pathways with global study teams, Start-Up Managers, Site Partnership functions, and CRA managers. 

• Represent the local TA perspective in broader country strategy discussions. 

Qualifications 

• Bachelor’s degree in life sciences or related field (Master’s or PhD preferred)