Director of Patient Operations
Lyell ImmunopharmaAbout the role
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 process—including 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
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