Associate Director, Clinical Supply Chain

Spyre Therapeutics, a clinical-stage biotechnology company, is seeking an experienced Associate Director, Clinical Supply Chain to independently lead end-to-end supply for assigned global studies. This role involves managing clinical demand, supply planning, and execution with a focus on global distribution, including country readiness, import/export execution, shipment tracking, and issue resolution.

The individual will work with high autonomy, influencing cross-functional teams and collaborating closely with CMC, Clinical Operations, Quality, Regulatory, CROs, CDMOs, and external providers to ensure uninterrupted, compliant, and cost-effective clinical supply.

Key Responsibilities:

Supply Chain Planning

• 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 balancing supply continuity, cost, and inventory exposure
• Support sourcing of comparator product and ancillary supplies, as required

Supply Chain Execution

• 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, 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

Global Distribution

• 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

Cross-Functional Leadership

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

General Project Management

• 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