Associate Director, Clinical Supply Chain

Associate Director, Clinical Supply Chain

US
- Remote

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next‑generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half‑life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.

We are seeking an experienced Associate Director, Clinical Supply Chain, to independently lead end‑to‑end supply for assigned global studies. This hands‑on individual contributor will manage clinical demand and supply planning and execution. Global distribution will be a key focus, including country readiness, import and export execution, shipment tracking and issue resolution.

Working with a high degree of autonomy, this individual will influence cross‑functional teams and partner closely with CMC, Clinical Operations, Quality, Regulatory, CROs, CDMOs, and other external providers to ensure uninterrupted, compliant, and cost‑effective clinical supply.

• Develop and maintain demand forecasts, supply plans, and scenario models using enrollment, dosing, randomization, manufacturing lead times, expiry, and inventory assumptions
• Monitor inventory, expiry, and resupply across multiple depots and sites; evaluate changes and implement mitigation plans that balance supply continuity, cost, and inventory exposure
• Support sourcing of comparator product and ancillary supplies, as required

• Develop and maintain the clinical supply strategy for IRT systems, including user requirements, user acceptance testing, configuration review, and optimization of supply settings
• Support review and approval of clinical supply documents, including label text, packaging specifications and batch records, pharmacy manuals, and applicable protocol, IND, and IMPD content
• Collaborate with partners to establish packaging/labeling schedules to ensure continuous availability of clinical supplies

• Oversee external partners in executing global distribution for assigned studies, including depot‑network strategy, inventory positioning, shipping lanes, country requirements, and contingency planning
• Drive country activation from a clinical supply perspective and import‑license readiness by maintaining country‑specific requirements and readiness trackers, closing documentation gaps, and escalating risks before planned shipments
• Review and coordinate import, export and customs documentation with CROs, CDMOs, Regulatory, importers of record, and other partners
• Manage reverse logistics, including returns, reconciliation, recovery, and destruction, in accordance with protocol, quality, and country requirements
• Build and monitor distribution metrics, including on‑time delivery and right first time; use trends to improve processes and partner performance

• Represent Clinical Supply Chain on study and program teams; lead supply discussions and communicate status, risks, tradeoffs, and recommendations to senior leaders and external partners
• Establish scalable processes, templates, governance, and performance standards, and lead continuous improvement across clinical supply operations.

• Maintain budget trackers, inventory and expiry dashboards, supply‑risk reporting, KPIs, and vendor‑performance metrics
• Forecast costs, monitor budget versus actual spend, review proposals, change orders, and invoices, and identify cost risks and savings opportunities
• Perform other duties as assigned

• Bachelor’s degree in life sciences, supply chain,…