Executive Director, Clinical Supply Management
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Job Description
Executive Director leading clinical supply strategy and operations for Jade Biosciences’ autoimmune disease biologics. Managing teams, CMOs, forecasting, distribution and regulatory readiness.
Responsibilities:
- Provide strategic and operational leadership for Jade’s Clinical Supply Management function
- Develop and scale the team through internal headcount and external partners, including recruiting, onboarding and mentoring team members and consultants
- Develop business processes and SOPs with the Quality function
- Define and implement clinical supply strategy for programs from Phase 1/2 through Phase 3, with forward planning for BLA filing, launch and commercial readiness
- Build and maintain global demand forecasts and supply plans based on protocols, enrollment projections and site activation plans
- Advise Senior Management and Clinical Operations and Development on supply risks and challenges
- Collaborate with Clinical Operations, Clinical Development, Quality, Regulatory Affairs and CMC
- Select, contract and manage clinical supply CMOs, depots, couriers, logistics providers and other critical suppliers
- Oversee labeling, packaging, blinding, cold-chain storage and global distribution of drug products
- Manage comparator sourcing, expiry extensions, relabeling, returns, reconciliation and destruction
- Define IRT/IxRS supply requirements and resupply strategies; monitor depot and site inventory
- Ensure compliance with SOPs, cGMP, GDP, GCP, ICH guidelines and global regulatory/import-export requirements
- Partner with Quality on batch release, QP release for EU studies, deviations and change controls
- Contribute to IND, IMPD and CTA regulatory submissions
- Manage the clinical supply budget
- Report to stakeholders and senior management on inventory, supply and demand, changes and risks
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
- Proven experience managing clinical supply for biologics in vials within cold-chain environments, using local and multinational CMOs
- 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)
- 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
- Exceptional communication, leadership and interpersonal skills
- Strong problem-solving skills and ability to thrive in a complex, fast-paced clinical development environment
Benefits:
- Remote work arrangement
- Periodic travel to team and company events
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