Senior Global Clinical Operations Program Director

AstraZenecaBoston, MA
Hybrid

About The Position

Are you ready to lead global cell therapy programs that accelerate breakthrough medicines to patients? As a Senior Global Clinical Operations Program Director, you will guide the operational delivery of an ambitious clinical development plan, translating strategy into measurable outcomes that matter for patients and the business. You will be a core leader on the Clinical Program Team, partnering across disciplines to enhance the scientific and clinical relevance of our cell therapy assets. In this role, you will integrate strategy, build, feasibility, and operational planning to deliver programs within defined parameters of scope, quality, budget, and schedule. You will build clinical program structures, champion creative approaches to compose and implementation, and ensure robust governance. Can you see yourself orchestrating complex, global studies and turning bold ideas into regulatory-ready results? This is your opportunity to influence direction at scale while developing high-performing teams and trusted partnerships that drive value.

Requirements

  • Bachelor of Science/Master of Science degree with a minimum of 10 years experience in related field, or equivalent work experience.
  • Extensive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
  • Extensive experience across the product life cycle with experience in Cell Therapy development and ideally across multiple therapeutic areas
  • Clinical operations knowledge with strong track record of delivery
  • Extensive knowledge of the clinical and pharmaceutical drug development process
  • Validated ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements
  • Significant experience of program management and use of project management techniques in complex projects, including resourcing, financial management and business case development
  • Proven ability to develop successful collaborations with internal collaborators and external partners
  • Strong strategic influencing skills: ability to influence broadly within and outside the organisation
  • Excellent written and verbal communication skills
  • Proven collaboration and ability to work collaboratively across a wide range of teams
  • Track record of planning, prioritisation and delivery success
  • Willingness to travel both domestic and international

Nice To Haves

  • Advanced degree is preferred
  • Demonstrated ability to drive process improvement and/or functional work
  • Cell Therapy Study Management Experience in a pharma/biotech setting
  • Experience of implementing changes in ways of working that focus on increasing efficiency
  • Regulatory submission experience
  • Previous success of working in Japan and China to ensure delivery of global programmes to meet business needs
  • Proven experience in leading teams through change
  • Experience of and insight into the Clinical environment to be able to drive major improvement programs
  • Experience in line management of leadership roles

Responsibilities

  • Lead end-to-end oversight of clinical program activities, advancing relevant issues to senior governance and providing clinical operations expertise in feasibility, country selection, operational input to design, risk management, and external partner management.
  • Use innovative design and delivery models to accelerate project start-up and informed decision-making.
  • Partner with the Global Clinical Head and the Biometrics Team Leader to set clear direction and shared goals for Clinical Program Team members and clinical delivery teams, ensuring cohesive execution.
  • As a core member of the Clinical Program Team, manage all clinical development deliverables to scope, quality, budget, and time.
  • Drive program strategy, study design, resourcing, and risk mitigation that translate into predictable delivery and business impact.
  • Establish team structures, governance, and ways of working that enable a high-performing Clinical Program Team focused on outcomes and continuous improvement.
  • Provide line management to global clinical operational leaders at the study and program levels, including Global Study Associate Directors or Global Study Directors and Global Program Directors aligned to the product team’s deliverables.
  • Serve as the line manager for Global Study Directors within your aligned product team.
  • Own the clinical operations components of regulatory submissions, support regulatory interactions and reporting, and lead clinical contributions to inspection readiness for marketing applications and post-registration maintenance.
  • Act as the initial and program-level operational work with outsourced partners (CROs/AROs) and collaboration/alliance partners.
  • Serve as AstraZeneca’s decision maker and critical issue point to ensure contract partners deliver to expectations.
  • Ensure timely compliance with company-wide governance controls, including financial oversight, planning and control, continuous assurance, and Clinical Trial Disclosure.
  • Manage clinical plans—cost, FTEs, and timelines—in business reporting systems such as PLANIT.
  • Lead or contribute to non-drug project work and cross-functional improvement initiatives.
  • Be an early adopter and ambassador for new ways of working, contribute as a Subject Matter Expert, mentor and coach colleagues, and actively network to share standard methodologies and takeaways.

Benefits

  • Inclusive environment where open doors and open dialogue fuel progress.
  • Opportunity to collaborate with leading academics, biotechs and industry partners.
  • Support from kind, engaging leaders who value ambition and continuous learning.
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