Associate Director, Clinical Supply Chain
About the role
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. Role Summary 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.
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.
- Supply Chain Planning: Monitor inventory, expiry, and resupply across multiple depots and sites; evaluate changes and implement mitigation plans that balance supply continuity, cost, and inventory exposure.
- Supply Chain Planning: 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.
- Supply Chain Execution: 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.
- Supply Chain Execution: 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.
- Global Distribution: 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.
- Global Distribution: Review and coordinate import, export and customs documentation with CROs, CDMOs, Regulatory, importers of record, and other partners.
- Global Distribution: Manage reverse logistics, including returns, reconciliation, recovery, and destruction, in accordance with protocol, quality, and country requirements.
- Global Distribution: 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, tradeoffs, and recommendations to senior leaders and external partners.
- Cross-Functional Leadership: 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.
- General Project Management: Forecast costs, monitor budget versus actual spend, review proposals, change orders, and invoices, and identify cost risks and savings opportunities.
- General Project Management: Perform other duties as assigned.
Requirements
- Bachelor’s degree in life sciences, supply chain, business, engineering, or a related field; an advanced degree is preferred.
- 6-8+ years of progressive clinical supply chain and logistics experience, including at least 5 years directly managing global clinical supply.
Qualifications
- Demonstrated independent ownership of complex blinded global Phase 2 or Phase 3 studies involving multiple product presentations, and/or combination products and devices.
- Demonstrated hands-on ownership of global clinical trial distribution across multiple regions, including country activation, import-license readiness, import and export documentation, customs clearance, and shipment execution.
Skills
- Advanced Excel skills and hands-on experience with clinical supply forecasting and optimization platforms (e.g. ERP) and IRT systems.
- Working knowledge of GMP, GDP, GCP, global import and export requirements, and applicable clinical supply regulations.
- Strong leadership presence and ability to influence cross-functional teams, senior stakeholders, and external partners without direct authority.
- Ability to assume ownership quickly with minimal onboarding and oversight, make risk-based decisions with incomplete information, manage competing priorities, and translate complex data into clear recommendations in a fast-paced environment.
- Highly organized and adaptable to change.
- Experience in a small biotechnology company, start-up, or similarly lean and rapidly evolving environment preferred.
Benefits
- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO