Associate Director, Clinical Supply Chain

Nuvalent - Cambridge, MA

Full-time - Senior

Cambridge, MA

Professional, Scientific, and Technical Services

About the position

The Associate Director, Clinical Supply Chain at Nuvalent, Inc. is responsible for managing all aspects of the clinical drug supply chain, including forecasting, label creation, packing, labeling operations, and clinical distribution management. This role involves collaboration with internal teams and external vendors to ensure an uninterrupted drug supply for global clinical trials, contributing to the efficiency and compliance of the Clinical Supply Chain.

Responsibilities

• Represent Clinical Supply Chain on Clinical Study teams and other clinical-related cross-functional meetings to ensure Clinical Trial Material supply milestones are met across all programs.
• Support clinical demand activities for both ongoing and new clinical trials, including demand forecasting, trial monitoring, resupply planning, label design, packaging vendor management, IRT setup, and distribution activities.
• Accountable for clinical labeling, packaging, and distribution.
• Lead Clinical Supply Strategy Planning (CSSP) review meetings to capture CTM demands, review bulk supply plans, address program risks, and review protocol states.
• Support the department budget, including vendor invoice review and monitoring planned vs. actual spend.
• Develop root cause analysis and risk mitigation strategies to address potential issues impacting the Clinical Supply Chain.
• Provide leadership in developing and implementing continuous improvement initiatives to enhance lead times and reduce supply chain risks.
• Collaborate with Clinical Operations, Quality Assurance, CMC, and Regulatory Affairs to ensure compliance and efficient delivery of clinical supplies.
• Build relationships with Clinical Research Organizations (CROs) for effective utilization of drug supply materials.
• Oversee vendor management, including Clinical Packagers, IRT vendors, and Distribution Depots.
• Lead and mentor Clinical supply managers.

Requirements

• Master's degree in a scientific field or equivalent experience.
• Ten (10)+ years of experience managing multiple Phase 1-4 and IIS studies in the Pharmaceutical and/or Biotech industry.
• Experience managing vendors with a strong understanding of regulatory requirements for labeling, packaging, and distribution of clinical trial materials.
• Knowledge of GMP/GXP trial documentation and familiarity with Trial Master File (TMF) requirements.
• Experience with temperature product management and forecasting tools.
• Proficiency in Microsoft applications (Excel, Word, PowerPoint, Project) and experience with automated inventory systems.

Nice-to-haves

• Additional Project Management Training (PMP) would be beneficial.
• Experience with automated applications like Smartsheet and ERP Inventory management.

Benefits

• Competitive salary range of $132K - $167K per year.
• Equal employment opportunities (EEO) without discrimination.