Associate, Clinical Logistics

The Clinical Logistics Associate is responsible for end-to-end clinical cell therapy logistics execution, including patient enrolment 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.ResponsibilitiesEnd-to-end Cell Journey ExecutionWorks with the clinical logistics digital systems manager and change manager to ensure enrollment readinessWorks with the CRO to acquire trial site information to pass to digital systems for configurationParticipates in trial Site Initiation Visit (SIV) trainingExecutes dry runs for trial sites that require itTravel as needed for in-person dry runsFacilitates trial participant registration in the Salesforce cell journey orchestration platformEnsures the trial participant meets clinical trial eligibility criteria prior to arranging apheresis collectionEnsures supply is at the trial site to facilitate apheresis collectionWorks with 3PLs to arrange transport of apheresis material to Kite manufacturingUses 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 manufacturingTracks manufacturing status and relays status and potential delays to the clinical trial siteWorks with manufacturing Site Planning and QA Product disposition to arrange timely transport of QA released final IP back to the clinical trial siteCommunicates 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 ManagementUses the ERP to submit and book cell order for manufactureVerifies cell order bookings to ensure accuracy and completeness in concert with other logistics staffSupply OrdersTracks and orders apheresis shipper kits for clinical trial sites to ensure clinical trial enrollment readinessEnsures 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 CRCsWorks with manufacturing Site Planning to order liquid nitrogen (LN2) dewars to enable shipment of final IPEnsures LN2 dewars are ordered early enough to ensure smooth operations and ensures dewars are returned immediately after useDevelopment EngagementParticipates in clinical trial Study Management Team meetingsEnsures SMT established clinical trial milestones are metProvides updates to the SMT on IP delivery status and logistics readinessManufacturing EngagementWorks with various functions at manufacturing to ensure smooth operationsNegotiates slot and confirms slot allocation with Site PlanningWorks with QA accessioning in the event of apheresis receipt issuesWork with QA Product disposition to resolve events impeding timely final IP release and distributionRegularly communicates with Site Planning to discern final product status for communication back to the clinical trial site in the event of a manufacturing delayCustoms and Health Authority ComplianceUses clinical logistics systems to generate customs invoices to ensure smooth cross-border transport of apheresis and final product IPWorks closely with GTC to provide visibility to all incoming and outbound cross-border shipmentsNotifies and works with GTC to resolve customs issues that arise in real-time an international borderWorks with manufacturing QA and RA as needed to facilitate country specific health authority shipment requirementsCommunicates with QP in countries that require in-country release to ensure timely delivery of final productOperational Readiness and CoverageEscalates execution risks and process gaps to management for awarenessEnsures logistics documentation is inspection ready and filed in accordance with applicable SOPs and eTMF requirementsMaintains complete and accurate CoI and CoC documentation for all shipmentsAnticipates logistics risks and works with 3PLs and clinical logistics management to mitigateMonitor active shipments, identify risks or deviations, and proactively triage and resolve logistics issues impacting patient treatment timelines.Serve as the day-to-day logistics point of contact for clinical trial sites, CROs, manufacturing sites, and internal stakeholders.Participate in the Clinical Logistics 24/7 on call rotation to support time critical logistics events outside standard business hours.OtherExecutes other duties as assigned by Clinical Logistics ManagementBachelor's degree in Life Sciences, Supply Chain, Business, Information Technology or related field preferredExperienceExperience in clinical logistics, clinical operations, or clinical supply chain within the biopharmaceutical industry.3+ years with a high school diploma0+ years with a bachelor's degreeBasic understanding of end-to-end clinical trial operations, including patient-specific logistics, global trial execution, and their impact on systems and operations.Any experience with cold-chain logistics or temperature-controlled biologicsAny experience with ERP systems (EBS, SAP, etc.)Any experience with clinical trial tools and systems (CTMS, EDC, eTMF, IRT, IXRS, etc.)Any experience with DCS and QMS systems (Veeva, Agile, etc.)Basic knowledge of GCP, GMP, GxP, ICH, IATA principles and regulatory requirements.SkillsExcellent communication, and collaborative skills.Strong problem-solving abilities.Ability to manage complexity and multiple priorities in a fast-paced environment.Proficiency with Microsoft Office, SharePoint, Smartsheet, and other business systemsAt Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.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 Gilead and help create possible, together., Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.#J-18808-Ljbffr