The incumbent is responsible for designing, implementing, and operationalizing the patient operations and scheduling processes to support clinical trials. Initially, the incumbent will focus on capability building (process, system, people, data). After clinical trial start start-up, this role will have the responsibility of managing day-to-day patient operations and scheduling at Lyell.
KEY ROLE AND RESPONSIBILITIES:
Cell Therapy scheduling and logistics
- Develop streamlined & scalable vein-to-vein supply chain process with robust Chain of Identify (COI) and Chain of Custody (COC).
- Works with Clinical Operations and Clinical sites to enroll patients following the capacity allocation plan to the extent practicable.
- Manages dynamic patient scheduling and associated logistics daily to ensure capacity is effectively used and the clinical program timelines are met.
- Leads ongoing patient scheduling communication between manufacturing sites, clinical sites, and transportation partners for patients in-process.
- Lead the roll-out of a Cell Orchestration Platform that will aid in the site/patient onboarding, scheduling and cell logistics processes
- Coordinate patient scheduling activities with external collaboration partners.
- Support the LyFE manufacturing center with the creation and maintenance of a detailed manufacturing schedule as we ramp up production towards clinical phase.
Clinical Site Certification and Onboarding
- Represent Tech Ops on the Site Certification Team that supports Clinical Operations to perform Site Certification for each clinical site.
- Leads supply chain operations with regards to apheresis center and cell lab – scope of activities includes labelling, packaging, logistics procedures, etc. Facilitates SFQ/STA completion, identifies potential gaps in collected responses, sets up audits (apheresis/cell lab), supports SOP development and training for technicians/nurses on cell tracking system usage. Answers on-demand questions around apheresis collection and cell processing.
- Leads treatment site supply chain startup activities with a focus on overall logistics/distribution and patient support (e.g., CAR-T digital platform use) including mock shipments and exception management simulations.
Production Capacity and Allocation Planning
- Establishes a 3-month rolling capacity allocation plan across the network to patients by clinical program/therapy that is updated weekly.
- Manage the daily availability of manufacturing slots and maintain allocations according to plan.
- Establish cold chain shipping and distribution strategy and processes for patient material (apheresis, drug product and tumor tissue)
- Manage apheresis kit and other component distribution to clinical / apheresis sites. Maintain the appropriate inventory levels at sites.
- Qualify logistics providers and set up the patient therapy supply chain including courier selection, container validation, etc.
- Manage data logging capabilities to maintain shipping conditions and Chain of Identify and Chain of Custody
- Anticipate risks and identify proactive measures to mitigate issues
- MBA or MSc with a minimum of 10 years’ experience
- 10 years of experience in biotech/pharmaceuticals, including at least 3-5 years in a Supply Chain or Patient Operations role.
- Experience in clinical planning, forecasting, supply/production planning, plant scheduling, logistics management
- Experience working with clinical / apheresis sites in a clinical trial setting preferred
- Experience managing teams, including leadership of both matrixed teams and direct reports
KNOWLEDGE, SKILLS AND ABILITIES:
- Strong familiarity with ERP systems, cell tracking systems, supply chain planning/management/optimization applications, and Lean concepts
- Effectively working across functions and locations
- Business acumen, including both industry, financial and regulatory perspectives
- Excellent interpersonal, communication and stakeholder management skills
- Successful track record in implementing and driving business processes that result in aligned objectives, right outcomes and timely stakeholder communications
- An innovative mindset, with an ability to embrace change, respect differences of opinion, communicate openly and build consensus
- Ability to be both strategic and detail focused with strong critical thinking skills
- Comfortable in a fast-paced small company environment. Ideal to have start-up experience as the environment mirror's our own.
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.