Director, Clinical Quality Assurance

Lyell Immunopharma • South San Francisco, CA

97d • $220,000 - $245,000 • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Salary range of $220,000 to $245,000, annually, with the opportunity to earn an annual bonus.
• Eligible to participate in Lyell's Equity Incentive Plan.
• Subsidized medical, dental and vision plans from the first day of employment.
• FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance.
• ESPP, a 401(k) Plan with Company match.
• Mass transit commuter benefits, cell phone reimbursement.
• 18 days' vacation, 9 days' sick leave, 8 observed holidays as well as a floating holiday.
• Summer and winter office shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree