Jadebiosciences
Executive Director, Clinical Supply Management
Boston; Remote; San Francisco; Seattle; Vancouver. Posted a month ago
The role
You will own clinical supply strategy, planning, and execution for all Jade programs. You will lead and scale the Clinical Supply Management function, managing a team and a global network of CMOs and logistics partners.
What you will do
- Provide strategic and operational leadership for the Clinical Supply Management function
- Develop and implement clinical supply strategy for all programs from Phase 1/2 through Phase 3
- Build and maintain integrated global demand forecasts and supply plans
- Partner with Clinical Operations and Clinical Development on study-specific supply strategies
- Select, contract, and manage clinical supply CMOs, depots, couriers, and logistics providers
- Direct labeling, packaging, blinding, cold-chain storage, and global distribution
- Manage comparator sourcing, expiry extensions, relabeling, returns, reconciliation, and destruction
- Define supply requirements for IRT/IxRS systems and monitor inventory
- Maintain compliance with SOPs, cGMP, GDP, GCP, ICH guidelines, and global regulatory requirements
- Manage the clinical supply budget and report to stakeholders
Required qualifications
- 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
- Significant experience leading teams
- 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
Nice to have
- Experience in commercial supply chain management
- Experience with pre-filled syringes and combination products such as autoinjectors
Before you apply
- Jade Bioscience participates in E-Verify
About the company
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases.