Senior Director, US Head Country Operations Management, Study Start-up & Site Partnership
AstraZenecaAbout the role
Job Title: Senior Director US Head of Country Operations, Study Start-up & Site Partnerships
Location: Boston, MA
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Introduction to Role:
The Senior Director, US Head of Country Operations, Study Start-up & Site Partnerships will lead the US operating model and end-to-end delivery of clinical studies—from early indication planning and feasibility through site selection, start-up, enrollment, data delivery, and close-out.
You will set strategy and priorities, proactively manage risks, and drive performance to deliver programs on or ahead of schedule, within budget, and in compliance with SOPs, ICH/GCP, and US regulations. You will build and develop high-performing leadership and country operations teams, align resources with portfolio needs, and foster a collaborative “One Alexion” culture with sites and institutions.
Working across R&D, Medical, Commercial, and other key functions, you will advance portfolio goals, expand US patient participation and trial diversity, and embed innovation, including AI and advanced analytics, into country operations. As the primary escalation point for the US, you will communicate risks and action plans transparently to regional and global COM leadership and contribute to broader priorities.
As a key member of the Regional and Global extended COM Leadership Team and the US affiliate extended leadership team, you will strengthen collaboration, visibility, and shared accountability across the organization. This role requires strategic and operational leadership, sound decision-making, and the ability to translate complex market, scientific, regulatory, and performance insights into data-informed strategies that support sustainable growth.
Accountabilities:
- 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.
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