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.
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 that balance 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 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
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, 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.
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
Ideal Candidate:
- 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
- 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, shipment execution
- 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
What We Offer:
- 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
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
The expected salary range offer for this role is $175,000 to $198,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.
Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.