Director, Country Operations Management (DCOM)
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 milestoneson 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 810, 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 810 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-outEnsure trial milestones and deliverables are achieved with high quality and within agreed timelinesRobust oversight of site performance, study documentation, eTMF completeness, and regulatory complianceProject Management & Operational Delivery
Monitor key performance indicators (KPIs) and operational metrics across assigned TA to ensure quality and consistencyIdentify and mitigate operational risks, issues, and roadblocks in collaboration with global study teams and local partnersDrive process improvements, standardization, and adoption of country-level best practicesLead transformation and change initiatives to strengthen the local Clinical Operations Management (COM) functionStakeholder & Vendor Engagement
Collaborate cross-functionally with local Medical Affairs, Regulatory, Legal, Development Quality, and other internal partnersManage external vendor performance, including CROs and FSPs, ensuring alignment with clinical objectives and standardsMaintain effective communication pathways with global study teams, Start-Up Managers, Site Partnership functions, and CRA managersRepresent the local TA perspective in broader country strategy discussionsQualifications
Bachelor's degree in life sciences or related field (Master's or PhD preferred)Minimum 7 years of experience in clinical research, including significant exposure to Phase 2 / 3 interventional trialsAt least 3 years of direct people management experience in clinical operationsDemonstrated success managing cross-functional and vendor relationshipsStrong working knowledge of ICH-GCP, global regulatory requirements, and local trial execution environmentsProven ability to drive delivery across multiple concurrent studies in a fast-paced, matrixed environmentExcellent communication, influencing, and stakeholder management skillsPreferred Qualifications
Previous experience as a field CRAExperience in rare or ultra-rare disease trials, including pediatric or complex patient populationsExperience with U.S.-based studies and site managementSolid background in inspection readiness, risk mitigation, and continuous improvement