VP, Head of Cell Therapy Clinical Operations

Job Title: VP Head of Cell Therapy Clinical Operations

Introduction to role:

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.

Accountabilities:

• 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 IIII 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.

Essential Skills/Experience:

• 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

Desirable Skills/Experience:

• Advanced scientific or clinical degree (e.g. PhD PharmD MD or equivalent) and deep experience in cell therapy development or related modalities.
• 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 manufacturingclinical 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.

When we put unexpected teams in the same room we unleash bold thinking with the power to
inspire life-changing -person working gives us the platform we need to connect work at pace and challenge
perceptions. Thats why we work on average a minimum of three days per week from the office. But that
doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual
flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Here your leadership will translate breakthrough science into real options for people living with cancer supported by a collaborative ecosystem that blends academic insight with industry pragmatism. You will tap into a global network that spans hundreds of pre-clinical collaborations across more than two dozen countries and a consortium of seven premier cancer centers accelerating answers to the toughest questions. We put unexpected teams in the same room value kindness alongside ambition and back bold ideas with sustained investmentso you can build capability shape standards for cell therapy trials worldwide and see your impact reach patients faster. With diverse voices at the table including nearly half of senior roles held by women you will find the sponsorship and challenge needed to grow while delivering outcomes that matter.

Call to Action:

Lead the next chapter of cell therapy clinical operationsstep in to set the standard scale what works and deliver trials that move the needle for patients worldwide.

Date Posted

Closing Date