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