VP, Head of Cell Therapy Clinical Operations

AstraZeneca • Gaithersburg, MD

4d • Hybrid

About The Position

Are you ready to build and lead the global engine that delivers cell therapy trials with speed, rigor, and scale? In this role, you will set the operational vision and standards that convert pioneering science into robust clinical evidence, ensuring our cell therapy portfolio moves confidently from early development through pivotal trials. What could you achieve by uniting strategy, execution excellence, and a high-performing team to accelerate options for patients?
As VP, Head of Cell Therapy Clinical Operations, you will drive end-to-end clinical delivery across multiple indications and geographies, shaping how we partner with investigators, treatment centers, and governance bodies to make high-quality decisions at pace. You will champion a consistent model for cell therapy operations, from site network strategy to regulatory preparedness, and develop the capabilities and culture that scale with our ambitions.

Requirements

• Develop, maintain, and implement a clinical operations strategy for delivery of the overall cell therapy portfolio ensuring consistent standards and creating synergies across the pipeline
• Global operational delivery of Phase I-III clinical trials in our cell therapy portfolio across therapeutic areas, including but not limited to, accountability for resources (internal and external), timelines and study quality
• Efficient collaboration with Global Product Teams, Therapeutic Area Leadership and other Support Functions around preparation for key governance investment decision meetings, including the operational strategies as well as budget/resourcing
• Support Cell Therapy Regulatory Submissions across all Therapeutic Areas and ensure appropriate resources and capabilities
• Lead a growing global Clinical Operations team with employees in several countries including but not limited to, the US, UK, Germany and Australia.
• Provide portfolio and study level clinical operations expertise to Therapeutic Area leadership teams and other internal stakeholders to advise optimal models of delivery for cell therapy programs
• Develop and maintain enterprise-level site network strategy with regards to engagement of global cell therapy clinical centers and creation of a global network of authorized treatment centers together with other internal stakeholders
• Acquire, retain and develop critical capabilities and talent in the Cell Therapy Clinical Operations Function to meet the development requirements of our cell therapy pipeline
• Build strong relationships with key stakeholders across the enterprise.
• Communicate the business priorities and vision to staff and ensure appropriate assignment and use of resources
• Ensuring excellence in the development, and implementation of appropriate processes, templates, guidelines, SOPs, tools and systems for successful clinical trial conduct and standardization across the enterprise

Nice To Haves

• Advanced scientific or clinical degree (e.g., PhD, PharmD, MD, or equivalent) and deep experience in cell therapy development or related modalities.
• At least 10 years of relevant clinical operations experience with min 5 years working in a leadership/cell therapy role.
• Proven leadership in building global site and authorized treatment center networks, including vein-to-vein operational models and chain-of-identity/chain-of-custody controls.
• Strong record of partnering with regulators and health authorities on complex clinical operations topics, including innovative trial designs and manufacturing–clinical interface.
• Demonstrated ability to scale organizations through change, implement fit-for-purpose digital tools, and drive process harmonization without sacrificing agility.
• Experience integrating external partners (CROs, academic groups, industry consortia) into a unified operating model with clear quality and performance standards.

Responsibilities

• Portfolio Strategy and Governance: Define and implement a cohesive clinical operations strategy for cell therapy, creating standards and synergies across the portfolio that enable faster, better decisions at key governance milestones.
• Global Trial Delivery: Oversee Phase I–III clinical execution across multiple therapeutic areas, accountable for timelines, quality, risk management, and resource optimization across internal teams and external partners.
• Regulatory Enablement: Anticipate and meet regulatory needs by aligning operational plans, data quality, and submission readiness across all programs and geographies.
• Team Leadership and Talent Development: Lead, grow, and inspire a global organization spread across multiple countries; attract and develop critical capabilities required for complex cell therapy trials.
• Site Network and Treatment Centers: Build and maintain an enterprise-level strategy for engaging global cell therapy centers and establishing a scalable network of authorized treatment centers in partnership with internal stakeholders.
• Stakeholder Partnership and Communication: Partner effectively with product teams, therapeutic leaders, and enabling functions to align budgets, resourcing, and operational strategies; communicate priorities and vision with clarity.
• Operational Excellence and Standardization: Ensure consistent processes, templates, SOPs, tools, and systems for cell therapy trial conduct, driving standardization and continuous improvement across the enterprise.
• Resource and Budget Stewardship: Make transparent, data-informed trade-offs that maximize portfolio value, balancing speed, quality, and cost while enabling sustainable growth.

Benefits

• Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree