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.

Executive Director, Clinical Supply Management at Jadebiosciences | JobZoey