K
Posted 7 hours ago
Associate Director, Clinical Supply Chain Management
Kiniksa PharmaceuticalsAssoc. Director, Clinical Supply Chain Management
Requirements
BS/BA degree, 6+ years Clinical Supply Chain experience, Knowledge of cGMP, GCP, GDP, Global distribution experience
Skills
Supply ChainGMPGCP
About the role
Responsibilities
- Provide end-to-end clinical supply leadership to ensure continuous supply of clinical trial material globally
- Lead selection, oversight, and performance management of clinical packaging, labeling, depots, and distribution vendors
- Oversee planning and execution of packaging and labeling campaigns and master schedule development
- Develop fit-for-purpose clinical supply strategies including IRT strategy and comparator sourcing
- Partner cross-functionally with Clinical Operations, Quality, Regulatory, CMC, and Finance
- Translate protocols into demand forecasts and manage integrated supply plans
- Lead global distribution and logistics strategy, including import/export and temperature-controlled shipments
- Own risk management for clinical supply and drive mitigation plans
- Manage and forecast clinical supply budgets, tracking spend and purchase orders
Requirements
- BS/BA degree required (advanced degree preferred)
- 6+ years of progressive experience in Clinical Supply Chain within biotech or pharma
- Experience leading contract packaging and labeling organizations
- Proven ability to implement risk-based supply strategies for early- to late-stage programs
- Strong understanding of global regulatory expectations (US, EU, APAC) for clinical supply
- Deep knowledge of cGMP, GCP, GDP, and pharmaceutical transportation requirements
- Extensive global distribution experience and familiarity with IRT providers
- Strong project/program management and cross-functional leadership skills
About the Company
Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.
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Kiniksa Pharmaceuticals · Lexington
