Sr. Manager Clinical Supply Operations

Legend Biotech is seeking a Sr. Manager Clinical Supply Operations  as part of the Technical Operations team based in Somerset, NJ.

Role Overview

Legend Biotech is seeking an experienced and driven Sr. Manager- Clinical Supply Operations to join our Technical Development team. This role will report to the Director of Patient Supply Strategy & Operations and be responsible for supporting hands on execution of global patient supply activities for early clinical Cell and Gene Therapy programs (Allogenic and In-Vivo). This role will coordinate investigational product planning, packaging and labeling, distribution, inventory, quality release, returns, reconciliation, and destruction across clinical sites, depots, CROs, and external vendors. The successful candidate will bring strong operational discipline, systems proficiency, vendor coordination, and cross-functional partnership to help ensure continuous, compliant supply of clinical trial material.

Key Responsibilities

• Coordinating supply activities across multiple studies, countries, sites, depots, vendors, and systems.
• Maintaining accurate inventory visibility while protocols, enrollment forecasts, shelf life, and country requirements evolve.
• Managing temperature excursions, expiry risk, documentation gaps, shipment issues, and competing operational priorities.
• Translating cross-functional inputs into timely, practical clinical supply actions and clear follow-up.
• Reliable execution of clinical supply plans, packaging and labeling activities, releases, and global distribution.
• Accurate demand forecasts, inventory reconciliations, expiry tracking, returns, and destruction records.
• Effective use and oversight of IRT, inventory, vendor, and documentation systems to maintain supply visibility and data integrity.
• Clear operational metrics, risk tracking, issue escalation, and inspection-ready clinical supply documentation.
• Execute day-to-day clinical drug supply activities across assigned trials to maintain availability of investigational product.
• Develop and maintain demand forecasts, supply plans, resupply parameters, inventory targets, and risk-mitigation actions in alignment with enrollment and protocol assumptions.
• Coordinate packaging, labeling, distribution, returns, reconciliation, and destruction activities with internal teams, CROs, depots, clinical sites, and external vendors.
• Support studies from start-up through closeout, including early-phase programs and evolving study requirements.
• Maintain clinical supply plans, pharmacy manuals, distribution instructions, and other study-specific operational documentation.
• Coordinate clinical label text, translation, review, approval, packaging, and pack-and-label reconciliation for global studies.
• Coordinate QA and, where applicable, QP release activities and ensure required documentation is complete before distribution.
• Manage distribution activities and shipment documentation in partnership with logistics providers, depots, customs support, and study teams.
• Coordinate temperature-excursion assessment, expiry management, product disposition follow-up, and documentation closure.
• Support inspection readiness by maintaining complete, accurate, and traceable clinical supply records, including eTMF filing as required.
• Serve as the operational point of contact for assigned packaging, labeling, depot, logistics, IRT, and other clinical supply vendors.
• Track vendor deliverables, timelines, performance, documentation, risks, and issue resolution; escalate when needed.
• Partner with Clinical Operations, CMC, Quality Assurance, Regulatory Affairs, Technical Development, and external partners on shelf life, inventory strategy, country needs, and study execution.
• Identify process gaps and implement fit-for-purpose improvements that support compliance, cost, timelines, data quality, and supply continuity.
• Support deviations, investigations, CAPAs, change controls, suspected non-compliance assessments, and governance activities related to clinical supply operations.
• Independently manage assigned studies and workstreams, prioritize competing activities, and provide clear status and risk updates.
• Lead operational meetings and ensure decisions, actions, owners, and due dates are documented and followed through.
• Provide guidance to junior team members and contribute to SOPs, work instructions, training, and continuous improvement as the function scales.

Requirements

• Bachelor’s degree in supply chain, life sciences, pharmacy, business, or a related discipline; equivalent relevant experience may be considered.
• Advanced degree or relevant clinical supply certification is preferred but not required.
• 6+ years of progressive experience in clinical supply operations, clinical drug supply, pharmaceutical supply chain, or closely related GMP operations within a sponsor, CRO, or clinical supply service provider environment.
• Demonstrated independent ownership of multiple studies, vendors, complex workstreams, or operational improvements is expected.
• Hands-on experience with clinical supply planning, demand forecasting, packaging and labeling, distribution, inventory management, reconciliation, returns, and destruction.
• Experience supporting global clinical trials and working with clinical sites, depots, CROs, packaging providers, logistics partners, and other external vendors.
• Experience with IRT and clinical supply or inventory systems; familiarity with CTMS, eTMF, vendor portals, ERP, reporting tools, or related platforms is preferred.
• Working knowledge of GMP requirements, QA/QP release, temperature excursions, expiry management, inspection readiness, and clinical trial documentation.
• Experience with oncology, biologics, cell and gene therapy, or other complex temperature-controlled products is preferred, not required.
• Strong operational ownership, attention to detail, follow-through, and ability to work independently in a fast-moving environment.
• Ability to interpret study needs, inventory data, forecasts, and system outputs and translate them into timely supply actions.
• Effective vendor-management skills, including timeline tracking, issue resolution, escalation, and performance follow-up.
• Comfort working across multiple systems and maintaining accurate, inspection-ready documentation.
• Strong problem-solving, risk-management, prioritization, and process-improvement skills.
• Clear written and verbal communication and the ability to collaborate effectively across Clinical Operations, CMC, Quality, Regulatory, Technical Development, and external partners.
• Ability to manage multiple studies and priorities while maintaining compliance, responsiveness, and supply continuity.

#Li-JR1

#Li-Onsite