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 studiesfrom 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 deliveryfrom indication planning and feasibility through site selection start-up enrollment data delivery and close-outto 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:

Where can I find out more

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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.

Total Rewards:

The annual base pay (or hourly rate of compensation) for this position ranges from $211655 to $317482. Our positions offer eligibility for various incentivesan 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 .

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.