Associate Director, Clinical Supply Chain

Role Summary

Associate Director of Clinical Supply Chain, reporting to the Senior Director, Clinical Supply Chain, responsible for planning, creating, implementing, building, and optimizing the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Olema’s programs. The role can be based in San Francisco or Cambridge and requires approximately 15% travel (domestic or international).

Responsibilities

• End to End clinical supply chain management
• Develop and implement global Clinical Supply Chain strategies
• Manage global inventories, shipping, and third-party manufacturers / logistics providers
• Develop and manage Interactive Response Technologies (IRT) systems
• Oversight packaging, labeling, and distribution activities at multiple vendors
• Generate and manage clinical labels
• Identify supply chain risks, escalate if needed, and close out risk items
• Partner with Clinical Operations to align on assumptions and build clinical supply to meet program demand
• Represent Clinical Supply Chain on study execution teams

Qualifications

• Late phase clinical development and clinical supply chain management
• Thorough knowledge of Good Manufacturing Practices (GMP)
• 10+ years of biotechnology/pharmaceutical industry experience in clinical supply chain management
• Inventory management and third-party logistics oversight experience
• Extensive experience managing forecast demands
• Prior experience managing global, large, late-stage studies with standard of care drugs
• Strong global shipping and customs experience
• Solid experience developing clinical labels
• Experience developing IRT specifications
• Hands-on experience and troubleshooting proficiency with QMS and purchasing systems
• Prior experience in oncology trials using small molecules is preferred
• Excellent project management skills

Education

• Bachelor's degree is required; Master’s degree is preferred

Additional Requirements

• Travel: approximately 15% domestic or international travel