Associate, Clinical Logistics

Gilead's Stockley Park; United States; À distance; USD 90 000 - 140 000; Plein temps

Résumé du poste

Gilead is seeking a Clinical Logistics professional to manage end-to-end operations for cell journey execution and site readiness across biopharmaceutical trials.

The role involves coordinating with CROs, manufacturing, and QA, ensuring traceability, and maintaining timely IP delivery while navigating regulatory shipping requirements.

Qualifications

• Experience in clinical logistics, clinical operations, or clinical supply chain within the biopharmaceutical industry.
• 3+ years with a high school diploma; 0+ years with a bachelor’s degree.
• Basic 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 biologics.

Responsabilités

• Coordinate enrollment readiness with the clinical logistics digital systems manager and CRO.
• Pass trial site information to digital systems for configuration; participate in SIV training.
• Oversee supply, transport, and traceability of apheresis materials and IP to manufacturing.
• Ensure regulatory compliance, customs and health authority requirements across shipments.
• Serve as day-to-day logistics contact for sites, CROs, and internal stakeholders.

Connaissances

Communication

Problem solving

Multitasking

MS Office

Formation

High school diploma

Bachelor's degree preferred

Outils

EBS SAP

CTMS

EDC

eTMF

IRT

IXRS

Veeva

Agile

Description du poste

Responsibilities

End-to-end Cell Journey Execution

• Works with the clinical logistics digital systems manager and change manager to ensure enrollment readiness
• 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
• 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
• Works with 3PLs to arrange transport of apheresis material to Kite manufacturing
• 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
• 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
• Ensures SMT established clinical trial milestones are met
• Provides updates to the SMT on IP delivery status and logistics readiness

Manufacturing Engagement

• Works with various functions at manufacturing to ensure smooth operations
• Negotiates slot and confirms slot allocation with Site Planning
• Works with QA accessioning in the event of apheresis receipt issues
• Work with QA Product disposition to resolve events impeding timely final IP release and distribution
• Regularly communicates with Site Planning to discern final product status for communication back to the clinical trial site in the event of a manufacturing delay

Customs and Health Authority Compliance

• Uses clinical logistics systems to generate customs invoices to ensure smooth cross-border transport of apheresis and final product IP
• Works closely with GTC to provide visibility to all incoming and outbound cross-border shipments
• Notifies and works with GTC to resolve customs issues that arise in real-time an international border
• Works with manufacturing QA and RA as needed to facilitate country specific health authority shipment requirements
• Communicates with QP in countries that require in-country release to ensure timely delivery of final product

Operational Readiness and Coverage

• Escalates execution risks and process gaps to management for awareness
• Ensures logistics documentation is inspection ready and filed in accordance with applicable SOPs and eTMF requirements
• Maintains complete and accurate CoI and CoC documentation for all shipments
• Anticipates logistics risks and works with 3PLs and clinical logistics management to mitigate
• Monitor 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.

Other

• Executes other duties as assigned by Clinical Logistics Management
• Bachelor's degree in Life Sciences, Supply Chain, Business, Information Technology or related field preferred

Experience

• Experience in clinical logistics, clinical operations, or clinical supply chain within the biopharmaceutical industry.
• 3+ years with a high school diploma
• 0+ years with a bachelor's degree
• Basic 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 biologics
• Any 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.

Skills

• Excellent 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 systems

At 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.