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Director, Clinical Supply Chain Operations & Global Logistics

External
Beeline Medicines logoBeeline Medicines · Boston, MA
Full-timeOn-site3w ago
ComplianceDocumentationForecastingGCPLeadership
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About the role

About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully. Job Summary: The Director, Clinical Supply Chain Operations & Global Logistics is a senior operational leader responsible for the end-to-end planning, execution, and oversight of clinical supply chain activities supporting the company's global clinical development programs. Reporting directly to the Chief Technical Operations Officer, this individual ensures that investigational medicinal products (IMPs) - spanning small molecules and biologics - are packaged, labeled, distributed, and tracked in compliance with global GMP, GDP, and regulatory requirements, and that clinical sites around the world receive the right product, in the right condition, at the right time. This role is the primary interface between CMC manufacturing, Clinical Operations,, Quality, and external and logistics partners, serving as the operational architect of a global clinical supply network that is reliable, scalable, and inspection ready. In a pre-commercial biotech environment, this leader must balance strategic supply chain design with hands-on execution, building infrastructure and processes that will scale from early-phase trials through global registrational studies. In addition to clinical supply management, this role is also responsible for shipping, logistics and trade compliance for all material shipments (intermediates, drug substance, drug product and analytical materials) to support the global manufacturing supply chain. Work Arrangement & Location: Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday . Additional on-site days may be required based on business needs, team priorities, or leadership direction. Essential Duties and Responsibilities: Design and lead the end-to-end clinical supply chain strategy for all active and planned clinical programs, encompassing demand forecasting, inventory planning, clinical packaging and labeling, IRT/IVRS configuration, distribution, and returns/destruction. Own the global IMP distribution network, including selection and governance of third-party logistics (3PL) providers, cold chain carriers, and depot partners across North America, Europe, and global regions; ensure temperature-controlled supply chain integrity from CDMO release through site delivery. Serve as the primary supply chain interface to Clinical Operations, ensuring clinical supply timelines are fully integrated into study startup plans, protocol amendments, site activation milestones, and enrollment projections. Lead clinical supply planning and demand forecasting across multiple concurrent trials, using IRT/IVRS data and enrollment modeling to optimize inventory levels, minimize waste, and prevent supply disruptions to clinical sites. Oversee clinical packaging, labeling, and secondary manufacturing activities at CDMO/CMO sites, ensuring compliance with country-specific labeling requirements, GMP expectations, and blinding requirements for randomized controlled trials. Manage import/export logistics and global trade compliance for IMP shipments across all active clinical geographies, including coordination of regulatory import permits, customs documentation, and country-specific distribution authorizations. Establish and govern relationships with CDMOs, 3PLs, comparator drug suppliers, and specialty logistics vendors; define performance expectations, conduct business reviews, and manage escalations to ensure supply reliability. Partner with Quality Assurance to ensure clinical supply chain operations meet GDP/GMP requirements; lead or support regulatory agency inspections, internal audits, and CDMO quality reviews as they relate to clinical supply. Build and maintain clinical supply chain SOPs, batch disposition records, chain-of-custody documentation, and reconciliation processes in alignment with ICH E6 (GCP), GMP, and GDP expectations; author and update pharmacy manuals, Investigator Brochure supply sections, and site handling guidance to ensure clinical site readiness across all active studies. Lead investigation of supply chain exceptions and deviations, including root c


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