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

AstraZeneca • Boston, MA

4d • $211,655 - $317,482 • Hybrid

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior