Alexion Pharmaceuticals, Inc. · 10 hours ago
Director, Country Operations Management
Boston, MA
Full-time
Hybrid
Director/Executive
$163K/yr - $244K/yr
7+ years expAlexion Pharmaceuticals, Inc. is seeking a Director, Country Operations Management to lead local study delivery for Phase 2 and 3 clinical trials. This role is responsible for overseeing operational trial milestones, managing a high-performing team, and ensuring compliance with regulations while driving performance and process improvements.
BiotechnologyHealth CareMedicalTherapeutics
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
Robust 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
Qualification
Required
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
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
Benefits
Qualified retirement programs
Paid time off (i.e., vacation, holiday, and leaves)
Health, dental, and vision coverage in accordance with the terms of the applicable plans
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
BioWorld Financial Watch
2026-01-17
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2025-12-20
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