Senior Director, US Head Country Operations Management, Study Start-up & Site Partnership

• Own and govern the US Country Operations model, including standards, processes, decision rights, resources, and ways of working aligned with portfolio priorities.
• Lead a Country Operations team of 65+ employees, building an inclusive, high-performing culture that strengthens leadership capability, collaboration, accountability, and global patient contribution.
• Direct end-to-end study delivery—from indication planning and feasibility through site selection, start-up, enrollment, data delivery, and close-out—to achieve timeline, budget, quality, and country commitments.
• Drive US enrollment and clinical trial diversity targets in alignment with the Clinical Trial Diversity Action Plan.
• Serve as the primary decision-maker and escalation point for US operations, proactively identifying risks, removing barriers, and communicating mitigation plans to the RHCO and VP, Global COM.
• Lead Study Start-up excellence, including contracting, budgeting, EC submissions, and site selection in partnership with Clinical Development and Medical Affairs, to improve cycle times and delivery reliability.
• Oversee the US institutional and site alliance strategy, including the Partner in Care Network, and strengthen relationships through consistent engagement, in-person site visits, clear action plans, and a “One Alexion” approach.
• Develop innovative site solutions and preferred vendor strategies that respond to portfolio needs and changes in the external environment.
• Ensure employees and FSP partners operate in compliance with Alexion/AZ SOPs, ICH/GCP, and US regulations, maintaining inspection readiness and complete, timely eTMF documentation.
• Partner across COM, Clinical Operations, Clinical Development, External Scientific Engagement, Medical Affairs, Commercial, Regulatory, AZ SMM, and other functions to align execution, address study-specific risks, and advance portfolio goals.
• Maintain expertise in US policies, regulations, and emerging clinical trial trends; translate complex issues into practical, timely solutions.
• Collaborate with other Heads of Country Operations to share insights, risks, and best practices that strengthen the broader COM organization.
• Use global metrics and KPIs to monitor study performance, identify opportunities, and drive continuous improvement, quality, and reliable delivery.
• Embed AI and advanced analytics across feasibility modeling, site selection, and enrollment forecasting, supported by strong data governance, change management, and measurable outcomes.
• Develop and execute a national workforce strategy that forecasts capability needs, optimizes organizational design, and aligns recruitment, talent pipelines, and resource plans with portfolio priorities.
• Build, coach, and retain a high-performing leadership team; set clear expectations, address performance needs, and ensure employees have meaningful development, training, succession, and talent plans.
• Optimize resources across development phases and therapeutic areas to deliver committed clinical program targets.
• Develop and manage country budgets in alignment with agreed RBU targets, including salary and bonus recommendations in partnership with the RHCO and local HR Business Partners.
• Lead transformation across country infrastructure, workforce, and processes to strengthen US performance and the overall COM organization.
• Deliver credible, data-informed feasibility and continuous feasibility plans, balancing analytics with local market intelligence and proactively sharing commitments, insights, and risks with global teams.
• Strengthen communication between the US team, including DCOM, and global study leadership, including GPD, while partnering with Country Quality and Regional Medical Advisor Pipeline/MSL colleagues to support quality, inspection readiness, and site relationships.
• Ensure a country-level post-trial access plan is established and that GPD teams understand its requirements and budget implications.

Essential Skills/Experience:

• Bachelor’s degree in life sciences or a related discipline.
• At least 10 years of clinical research experience in Clinical Operations, with direct involvement in clinical trials and a strong understanding of the clinical drug development lifecycle.
• Proven experience leading a large-scale Clinical Operations function within a pharmaceutical or biotechnology environment, including direct and indirect people leadership.
• Demonstrated success developing, coaching, and inspiring high-performing teams, with an ability to establish clear roles, shared goals, and accountability.
• Experience developing operational strategies and delivering global and local clinical trials across multiple projects, including translating scientific objectives into practical execution plans.
• Strong knowledge of the US clinical trial environment, rare disease landscape, global regulatory requirements, and ICH/GCP guidelines.
• Experience implementing, monitoring, and managing clinical trials, functional and cross-functional teams, SOPs, and operational processes.
• Ability to lead decisively in a complex matrix environment, delegate effectively, manage competing priorities, and adapt to changing business and portfolio needs.
• Collaborative leadership style with the ability to build trusted relationships and influence internal and external stakeholders, including senior leaders, alliance partners, sites, and vendors across cultures and functions.
• Demonstrated learning agility, resilience, and comfort navigating ambiguity and change while identifying opportunities to improve performance and create value.
• Strong portfolio and project management capabilities, including operational planning, financial management, resource planning, and budgeting.
• Clear and transparent written, verbal, and presentation skills, with the ability to communicate effectively at all organizational levels.
• Strong problem-solving, organizational, negotiation, and relationship-building skills.
• Ability to adapt to evolving technologies and processes, with practical AI literacy and an interest in using innovation to improve clinical operations.
• Ability to travel nationally and internationally for at least 25% of the role, depending on program needs, with flexibility to accommodate changing schedules.

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At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.