Director, Country Operations Management

Alexion•Boston, MA

11d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.
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.
R obust oversight of site performance, study documentation, eTMF completeness, and regulatory compliance.
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.
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.