Associate, Clinical Logistics

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

The Clinical Logistics Associate is responsible for end-to-end clinical cell therapy logistics execution, including patient enrollment readiness, apheresis coordination, manufacturing tracking, and final product delivery for pivotal trials. The role ensures chain of identity/custody integrity, manages orders and critical supplies, and works closely with clinical, manufacturing, global trade compliance, and 3rd party logistics (3PL) couriers. The associate tracks shipments and risks, serves as the primary point of contact for logistics product status, and proactively resolves issues to ensure the safe and timely delivery of Kite’s lifesaving therapies.

This position requires 24/7 On Call Rotation

Responsibilities

End-to-end Cell Journey Execution

·      Works with the clinical logistics digital systems manager and change manager to ensure enrollment readiness

o   Works with the CRO to acquire trial site information to pass to digital systems for configuration

·      Participates in trial Site Initiation Visit (SIV) training

·      Executes dry runs for trial sites that require it

o   Travel as needed for in-person dry runs

·      Facilitates trial participant registration in the Salesforce cell journey orchestration platform

·      Ensures the trial participant meets clinical trial eligibility criteria prior to arranging apheresis collection

·      Ensures supply is at the trial site to facilitate apheresis collection

o   Works with 3PLs to arrange transport of apheresis material to Kite manufacturing

o   Uses the cell journey orchestration platform, 3PL systems, and communication with trial site to ensure product traceability and unbroken chain of identity (CoI) and chain of custody (CoC).

·      Tracks customs clearance and confirms delivery of apheresis product at manufacturing

·      Tracks manufacturing status and relays status and potential delays to the clinical trial site

·      Works with manufacturing Site Planning and QA Product disposition to arrange timely transport of QA released final IP back to the clinical trial site

·      Communicates expected delivery date to the clinical trial site and Study Management Team (SMT)

·      Tracks product pick-up, transit, and delivery of the final IP to the clinical trial site using the Salesforce cell journey orchestration platform, 3PL systems, and direct communication with the trial site and 3PL.

Cell Order Management

·      Uses the ERP to submit and book cell order for manufacture

·      Verifies cell order bookings to ensure accuracy and completeness in concert with other logistics staff

Supply Orders

·      Tracks and orders apheresis shipper kits for clinical trial sites to ensure clinical trial enrollment readiness

·      Ensures on-site (trial site) apheresis shipper kits are not expired using tools provided by clinical logistics management as well as by direct confirmation with trial site CRCs

·      Works with manufacturing Site Planning to order liquid nitrogen (LN2) dewars to enable shipment of final IP

o   Ensures LN2 dewars are ordered early enough to ensure smooth operations and ensures dewars are returned immediately after use

Development Engagement

·      Participates in clinical trial Study Management Team meetings

o   Ensures SMT established clinical trial milestones are met

o   Provides updates to the SMT on IP delivery status and logistics readiness

Manufacturing Engagement

·      Works with various functions at manufacturing to ensure smooth operations

o   Negotiates slot and confirms slot allocation with Site Planning

o   Works with QA accessioning in the event of apheresis receipt issu