Director, Patient Cell Supply Chain Bothell, Washington, United States; South San Francisco, California, United States

Director of Patient Operations

Using living cells to treat and sometimes even cure cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell's product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. This role is a hybrid role and can be based out of our Bothell, Washington or South San Francisco, California.

Position Summary

The Director of Patient Operations within the Technical Operations organization will oversee the daily execution and long-term evolution of Lyell's Patient Operations function, support an expanding portfolio of cell therapy clinical trials and prepare for future commercial launch. This high-impact role is responsible for managing the full vein-to-vein patient logistics processincluding scheduling, cell collection, drug product distribution, and clinical site enablement. The Director will lead a team of managers and cross-functional contributors, ensuring operational excellence, system readiness, and compliance with regulatory and quality standards. This individual will also play a critical leadership role in building Lyell's operational infrastructure to support a Biologics License Application (BLA) and commercial scale-up.

Key Role and Responsibilities

• Oversee end-to-end cell logistics operations, including scheduling apheresis shipments to the Lyell manufacturing site and final drug product deliveries to clinical sites.
• Ensure Chain of Identity (COI) and Chain of Custody (COC) integrity across the full patient journey.
• Ensure Patient Operations functions as the primary escalation point for resolving operational issues that may affect patient treatment timelines.
• Collaborates with Clinical Operations and Clinical sites to register and schedule patients in alignment with the capacity allocation plan.
• Coordinate ongoing patient scheduling communications between Lyell's manufacturing site, clinical sites, and transportation partners.
• Own relationships with specialty couriers, ensuring timely, GxP-compliant, and monitored cell shipments.
• Oversee cold chain logistics strategy and processes for apheresis and drug product shipments.
• Responsible for apheresis kit and other component distribution to clinical and apheresis sites. Maintain the appropriate inventory levels at sites.
• Partner with Quality to audit, assess, and qualify courier vendors in preparation for commercial operations.
• Lead onboarding, training, and performance management for Apheresis and Treatment Centers with respect to patient scheduling, logistics and cell handling.
• Own and regularly update operational manuals and training content for apheresis collection and drug product administration, ensuring alignment with evolving procedures and compliance standards.
• Responsible for the oversight and execution of training for clinical sites on the Apheresis Manual and Drug Product Administration Manual.
• Coordinate mock shipments and readiness assessments prior to site activation.
• Represent Technical Operations during clinical site activation to ensure operational readiness.
• Manage, triage, and escalate logistical or operational issues from clinical sites during apheresis or infusion.
• Manage deviations and potential CAPAs related to non-compliant handling of patient cells or other departures from procedures outlined in the apheresis and drug product administration manuals.
• Ensure validated, GPS-monitored, and environmentally controlled containers are used throughout the cell supply chain.
• Collaborate with internal teams (Manufacturing, Quality, Clinical Ops) and external partners (CROs, vendors) to maintain readiness and compliance.
• Work with Quality Assurance and other internal business partners to monitor, assess and qualify apheresis collection sites in preparation for commercial operations.
• Coordinate with Clinical Operations, Scheduling, Manufacturing, and Quality to ensure an up-to-date rolling plan for patient capacity and allocation.
• Responsible for daily manufacturing patient slot allocation.
• Work closely with Manufacturing and Scheduling to react to scheduling changes.
• Lead and grow a high-performing, collaborative team including direct reports and matrixed contributors.
• Provide oversight to managers responsible for Scheduling & Logistics and Apheresis / Infusion Operations.
• Serve as a key point of contact for Clinical Operations, Clinical Development, Manufacturing, Quality, Regulatory, and external partners related to patient operations.
• Represent Patient Operations in leadership forums and communicate risks, mitigations, and KPIs to senior management.
• Lead development and continuous improvement of SOPs governing Patient Operations.
• Drive the implementation and optimization of electronic tools and workflows to enable scalable, compliant operations.
• Serve as the business owner for the Cell Orchestration platform, ensuring system readiness for clinical and commercial use.

Preferred Education & Experience

Knowledge, Skills and Abilities