Director Study Leader, Cell Therapy

The Director Study Leader, Cell Therapy is responsible for delivering one or several smaller Cell Therapy development programs or leading multiple Cell Therapy studies, including complex and novel studies such as platform and basket trials. The specific accountabilities will vary based on the nature of the clinical studies or program. Reporting to the Sr. Director Group Leader, Cell Therapy, you may also provide expert input to non-drug programs and process improvement projects.

Accountabilities

• Provide clinical operational input into project or study level documents and may lead the delivery of study documents.
• With oversight from the Clinical Program Director, Cell Therapy, lead and deliver outstanding and operational options for review at Investment Decision Governance interactions.
• Lead the delivery of clinical study(s) or program(s) from concept to final CSR and through to study closure and archiving, ensuring adherence to budget, time, project standards, quality, and scientific standards.
• Optimize the performance of study delivery teams ensuring GCP compliance, including providing accurate performance feedback for study team members to the appropriate AZ manager or CRO representative.
• Maintain oversight throughout the life of the study or program, ensuring overall deliverables are met.
• May have 5 direct/indirect reports.
• Implement agreed study level processes and technology for assigned Cell Therapy clinical studies.
• Lead risk management/mitigation plans to ensure delivery to quality, budget, and time, raising issues to partners as necessary.
• Provide input to forecasting and management of study delivery costs, resources, and timelines.
• Ensure quality of study/program planning information into relevant planning systems (e.g., PLANIT) in collaboration with counterparts in relevant therapeutic areas.
• Guide the Study Team in developing outsourcing specifications and vendor selection.
• Provide procurement with clear specifications for study or program-specific outsourcing.
• Review and operationally approve study or program-specific contracts or work orders.
• Lead all aspects of CROs and other clinically outsourced third-party vendors.
• Communicate study level reports and status updates for assigned Cell Therapy studies, including progress issues
• Lead risk management and quality efforts to ensure study compliance and inspection readiness for apheresis and cell therapy infusion activities.
• May lead study delivery-related activities associated with regulatory inspections/audits in liaison with Clinical QA for apheresis and cell therapy infusion activities.
• Contribute to operational interactions with external entities including regulatory agencies, preferred partners/suppliers, and external collaborators.
• Responsible for the submission of essential documents to the Trial Master File, maintenance, and final closeout.

Essential Skills/Experience

• BS degree in related field or biological science
• 10 years drug development experience
• 5 years leading studies/programs in clinical development
• 3 years of direct Cell Therapy experience
• Clinical drug development process knowledge
• Leading delivery through internal and external organizations
• ICH-GCP principles
• Selection and oversight of external providers and development/providing clear requirements of contracts
• Early phase clinical delivery and in autologous or allogeneic therapies in oncology

The annual base salary for this position ranges from $162,566.00 to $243,849.66. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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

At AstraZeneca, we follow the science and pioneer new frontiers. Join our dedicated Oncology team with an ambition to eliminate cancer as a cause of death. Our vision unites and inspires us as we push forward with cutting-edge science and technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we aim to deliver six new molecular entities by 2025. Be part of a place built on courage, curiosity, and collaboration where bold decisions are driven by patient outcomes. Empowered at every level, you will have the opportunity to build a rewarding career while improving the lives of millions with cancer.

Ready to make a difference? Apply now!