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 forexecution 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 USregulations. 

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 managersand 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 mitigateoperational 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) 

• Minimum 7 years of experience in clinical research, including significant exposure to Phase 2/3 interventional trials 

• At least 3 years of direct people management experience in clinical operations 

• Demonstrated success managing cross-functional and vendor relationships 

• Strong working knowledge of ICH-GCP, global regulatory requirements, and local trial execution environments 

• Proven ability to drive delivery across multiple concurrent studies in a fast-paced, matrixed environment 

• Excellent communication, influencing, and stakeholder management skills 

Preferred Qualifications 

• Previous experience as a field CRA 

• Experience in rare or ultra-rare disease trials, including pediatric or complex patient populations 

• Experience with U.S.-based studies and site management 

• Solid background in inspection readiness, risk mitigation, and continuous improvement 

The annual base pay for this position ranges from $162,566.40 to $243,849.60. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.