Jade Biosciences - Executive Director, Clinical Supply Management
Requirements
• Bachelor’s or Master’s degree (or equivalent) in Life Sciences, Chemical Engineering or a related field. • 15+ years of progressive experience in clinical supply chain management, ideally with biologics, including significant experience leading teams. Experience in commercial supply chain management is a plus. • Proven experience managing clinical supply for biologics in vials within cold-chain environments, using local and multinational CMOs; experience with pre-filled syringes and combination products such as autoinjectors highly preferred. • Experience supporting multiple early- and late-stage programs, including multi-country Phase 3 studies and bridging studies for biologic combination products. • Comprehensive understanding of global regulatory and import/export requirements across Europe, North America, China, Japan and Rest of World (ROW), and strong working knowledge of cGMP, GDP and GCP. • Hands-on experience with IRT/IxRS systems, clinical supply forecasting tools and budget management. • Demonstrated success building and scaling clinical supply functions, including hiring, onboarding and managing team members and consultants to meet critical milestones. • Exceptional communication, leadership and interpersonal skills, with a track record of aligning CMC, Quality, Regulatory Affairs and Clinical teams and building trusting relationships with external CMO partners. • A strategic thinker with a proven execution record, strong problem-solving skills and the ability to thrive in a complex, fast-paced clinical development environment.
Responsibilities
• Lead and build the function: Provide strategic and operational leadership for Jade’s Clinical Supply Management function. Further develop and scale the team through a combination of internal headcount and external partners, including recruiting, onboarding and mentoring team members and consultants. Develop robust business processes and SOP in close collaboration with the Quality function. • Lead and build the function: • Define the clinical supply strategy: Develop and implement the clinical supply strategy for all Jade programs, from early-stage (Phase 1/2) through late-stage (Phase 3) development, with a forward-looking view toward BLA filing, product launch and commercial readiness. • Define the clinical supply strategy: • Plan demand and supply: Build and maintain integrated global demand forecasts and supply plans based on protocols, enrollment projections and site activation plans. Balance drug product availability, shelf life, overage and cost, and update plans as studies evolve. Advise on potential risk and challenges to Senior Management and peer groups such as Clinical Operations and Development. • Plan demand and supply: • Collaborate cross-functionally: Partner closely with Clinical Operations and Clinical Development on study-specific supply strategies, and with Quality, Regulatory Affairs and CMC to forecast, align and continuously update supply requirements for ongoing and future studies. Develop options and recommendations for stakeholders and senior management. • Collaborate cross-functionally: • Select and manage CMOs and suppliers: Select, contract and manage clinical supply CMOs, depots, couriers, logistics providers, and other critical suppliers. Set clear performance expectations and KPIs, and build strong partnerships that ensure quality, reliability and cost-effective supply. • Select and manage CMOs and suppliers: • Oversee clinical supply operations: Direct labeling, packaging, blinding, cold-chain storage and global distribution for all drug product formats, including vials, pre-filled syringes and autoinjectors. Manage comparator sourcing, expiry extensions, relabeling, returns, reconciliation and destruction. • Oversee clinical supply operations: • Manage IRT and inventory: Define supply requirements for IRT/IxRS systems, including resupply strategies and user acceptance testing, and monitor inventory at depots and sites to prevent stock-outs and minimize waste. • Manage IRT and inventory: • Ensure compliance and quality: Maintain full compliance with Jade SOPs, cGMP, GDP, GCP, ICH guidelines and applicable global regulatory and import/export requirements. Partner with Quality on batch release (including QP release for EU studies), deviations and change controls, keep the function inspection-ready, and contribute to regulatory submissions (IND, IMPD, CTA). • Ensure compliance and quality: • Own the budget and reporting: Manage the clinical supply budget, and report regularly and concisely to stakeholders and senior management on inventory, supply and demand, changes and risks across all programs. • Own the budget and reporting:
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