Director of Patient Operations

 

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, 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 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: 

• Bachelor’s degree in a relevant field required, with minimum of 10 years’ relevant work experience; advanced degree (e.g., MBA, MS, PharmD, or similar) preferred
• 10+ years of experience in biotechnology, pharmaceutical, or cell and gene therapy industry, with at least 5 years in a leadership role overseeing patient operations, clinical logistics, or cell therapy supply chain.
• Proven success supporting clinical-stage programs, ideally through late-stage development and preparation for Biologics License Application (BLA) or commercial launch.
• Strong experience managing specialty couriers, cold chain requirements, and GxP-compliant transport of patient materials.
• Hands-on experience onboarding and managing Apheresis and Treatment Centers, including training, performance monitoring, and compliance oversight.

KNOWLEDGE, SKILLS AND ABILITIES:

• Deep understanding of vein-to-vein workflows, including apheresis collection, drug product distribution, cold chain logistics, and clinical site coordination.
• Familiarity with chain of identity (COI) and chain of custody (COC) requirements, including the use of tracking and orchestration platforms.
• Demonstrated ability to lead and grow high-performing teams in a cross-functional and fast-paced environment.
• Experience implementing or owning digital logistics/orchestration platforms is highly desirable.
• Strong collaboration skills with cross-functional partners including Clinical Operations, Manufacturing, Quality, Regulatory, and external vendors.
• Excellent organizational, problem-solving, and communication skills; ability to manage complex logistics with a patient-first mindset.

 

 

 

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

 

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.