Manager/Sr. Manager, Patient Supply Operations

Legend Biotech is seeking a Manager/Sr. Manager, Patient Supply Operations as part of the Patient Supply Strategy & Operations team based in Somerset, NJ.

 

Role Overview

Legend Biotech is seeking an experienced and driven Manager/Sr. Manager- Patient 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 is accountable for operational readiness of investigational product supply from IND through First-In-Human and early Phase studies, in alignment with regulatory requirements. The successful candidate will translate clinical and CMC needs into executable supply plans, ensure compliant distribution, inventory control, and QP release, and partner cross functionally to enable uninterrupted delivery of product to global clinical sites. This is a hands-on role requiring strong ownership of execution, vendor oversight, accountability, independent issue resolution in a fast-moving early phase environment.

Key Challenges

• Building global supply chain infrastructure in an early-phase, rapidly evolving environment.
• Executing first-time country start-ups, particularly in ex-US regions with regulatory requirements.
• Managing import/export processes and IOR/EOR models across multiple countries.
• Ensuring reliable delivery of temperature-sensitive products (LN2, -80°C).
• Responding to real-time logistics issues while maintaining compliance and timelines.

Key Deliverables

• Execution of FIH and early-phase global clinical shipments.
• Establish global depot and logistics network, including ex-US infrastructure.
• Define and implement import/export workflows and IOR/EOR models.
• Execute per country-specific clinical supply playbooks and SOPs.
• Operational cold-chain distribution lanes with defined performance metrics.

 

Key Responsibilities

Supply Planning Execution

• Own and execute global patient supply for early‑phase programs, aligned with clinical development plans and evolving protocol requirements as per program strategy.
• Operationalize bulk vs. per‑patient distribution strategies, safety stock policies, and contingency plans.
• Assist in developing supply manuals and SOPs for global clinical distribution including country specific clinical supply playbooks covering labeling, distribution, and inventory models.
• Support Label design for primary and secondary packaging for the drug products in compliance with regional requirements.

Global Logistics, Distribution & Import/Export

• Manage end-to-end global shipments including preparation of shipping documentation and coordination with couriers and custom brokers.
• Lead and execute import/export processes, including establishment and oversight of Importer of Record (IOR) and Exporter of Record (EOR) models.
• Support country start-up activities, particularly in ex-US regions (EU, APAC, LATAM).
• Support in selection, qualification, and operational readiness of global depots.
• Oversee cold-chain logistics (LN2 and -80°C), including lane qualification and performance monitoring.
• Serve as escalation point for real-time shipment issues (customs delays, temperature excursions, documentation gaps).

Inventory and Systems Management

• Lead evaluation, execution, and implementation of inventory management systems (e.g., SAP, IRT, third-party depots, clinical sites) for DP and APH materials.
• Own global inventory controls, including lot status, expiry management, returns, reconciliation, and destruction.
• Monitor depot and site inventory levels; proactively manage resupply and risk scenarios.
• Develop dashboards, KPI, and reporting to support supply decision-making.

Quality, Compliance and Risk Management

• Partner with Quality to ensure QP release processes are operationally executable, and documented.
• Support selection and readiness of depots, including licensing, permits, and quality requirements, in collaboration with Quality.
• Support deviation management, CAPAs, and change controls related to patient supply operations.

Vendor & Cross-Functional Leadership

• Provide senior oversight of CMOs, depots, couriers, and CROs.
• Serve as patient supply partner to Clinical Operations, CMC, Quality, Regulatory, and Technical Development.
• Lead SOP development, governance forums, and continuous improvement initiatives.
• Mentor junior team members as the function scales.

 

Requirements

• BS or MS Degree in Supply Chain, Pharmacy or equivalent discipline is required . Advanced technical training and experience preferred.
• 8+ years of experience in clinical supply chain, patient supply, or GMP operations within a sponsor or CRO environment.
• Demonstrated strategic ownership of early‑phase (FIH, Phase I) patient supply programs.
• Direct experience supporting allogeneic and/or in‑vivo therapies, including complex cold‑chain and non‑patient‑specific supply model is preferred.
• Proven expertise managing global clinical shipments. Experience with GMP, cell therapy logistics is highly desirable.
• Experience with temperature-controlled shipments, logistics, and E-Systems is highly desirable.
• Development of collaboration, influencing, and negotiation skills to work effectively with internal cross- functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.
• Collaborative, team-oriented mindset with strong verbal and written communication skills.
• Ability to communicate clearly and effectively with all levels of the organization.
• Understanding of escalation processes and requirements.
• Good written and verbal skills.
• Ability to work hands on, independently and successfully prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.

 

The advertised pay range covers both levels of this position.

 

Here's the base pay range by level:

 

Manager, Patient Supply Operations - $110,706 - $145,303

Sr. Manager, Patient Supply Operations - $127,313 - $167,099

 

 

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