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

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.
• 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.

Where can I find out more?

• Follow AstraZeneca on LinkedIn
• Follow Alexion on LinkedIn
• Follow AstraZeneca on Facebook
• Follow AstraZeneca on Instagram
• Learn more about Alexion at www.alexion.com

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.

Total Rewards:

The annual base pay (or hourly rate of compensation) for this position ranges from $211,655 to $317,482.Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Alexion embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Alexion is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.