Senior Manager, Global Clinical Supply Operations

Legend Biotech USA; New Jersey; On-site; USD 150,000 - 185,000; Full time

Job summary

Legend Biotech USA is seeking a Sr. Manager Clinical Supply Operations in Somerset, NJ to lead global clinical supply planning, packaging, labeling, distribution, and inventory for early cell and gene therapy programs.

You will drive cross-functional collaboration with Clinical Operations, CMC, QA, and external vendors to ensure compliant, timely supply of investigational products. You will oversee demand forecasting, temperature-control management, and inspection-ready documentation across

Qualifications

• 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.

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; escalation 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.

Job description

Legend Biotech USA is seeking a Sr. Manager Clinical Supply Operations in Somerset, NJ to lead global clinical supply planning, packaging, labeling, distribution, and inventory for early cell and gene therapy programs.

You will drive cross-functional collaboration with Clinical Operations, CMC, QA, and external vendors to ensure compliant, timely supply of investigational products. You will oversee demand forecasting, temperature-control management, and inspection-ready documentation across