Sr. Manager of Clinical Supply Chain

Roles & Responsibilities

• Lead end-to-end clinical supply planning and execution across multiple studies, including demand forecasting, supply planning, packaging/labeling, distribution, returns, reconciliation, disposition/destruction, and study closeout
• Partner cross-functionally to align supply strategy with clinical timelines and key milestones (e.g., FPI, LPLV/LPLD), ensuring supply continuity and risk mitigation
• Establish and manage inventory strategies (e.g., buffer levels, resupply approaches, expiry management) to balance availability with efficiency
• Collaborate with study teams to develop and maintain demand forecasts, incorporating protocol updates, enrollment trends, and site-level variability
• Identify and manage supply risks, including escalation, root-cause analysis, and implementation of mitigation strategies
• Oversee execution with external partners (e.g., manufacturing, packaging, logistics, and clinical service providers), including performance monitoring and issue resolution
• Support interactive response technology (IRT) strategy and execution, including system setup, testing, and alignment with supply plans
• Maintain accurate inventory visibility across materials and systems; support reconciliation activities and data quality checks
• Ensure clinical supply documentation is complete, accurate, and inspection-ready
• Partner with Quality and Regulatory functions to ensure compliance with applicable requirements and standards
• Contribute to process improvements, SOP development, and implementation of best practices
• Provide regular status updates, reporting, and input into budget tracking and cost management activities
• Mentor and provide guidance to team members as needed

Required Qualifications

• Bachelor’s degree in Life Sciences, Supply Chain, Pharmacy, Business, or a related field (advanced degree preferred)
• 7+ years of experience in pharmaceutical or biotechnology environments with direct clinical supply chain responsibility
• Experience working in Small Molecules & Solid Oral Dosages
• Experience supporting clinical trials across multiple sites and regions
• Strong knowledge of demand forecasting, supply planning, packaging/labeling operations, logistics, and reconciliation processes
• Experience working with external vendors and service providers
• Working knowledge of GMP/ICH guidelines related to clinical supply
• Proficiency with Excel and familiarity with supply chain and clinical systems (e.g., IRT, inventory tools)
• Strong communication, organizational, and problem-solving skills
• Ability to operate effectively in a fast-paced environment and manage competing priorities

Preferred Qualifications

• Advanced degree in a related discipline
• Experience supporting solid oral dose or other pharmaceutical dosage forms
• Familiarity with multiple IRT systems or clinical logistics platforms
• Project management certification (e.g., PMP)
• Experience with global supply considerations such as import/export and customs processes