Head of Supply Chain Operations

Essential Duties and Responsibilities

• Lead the overall Supply Chain Team, with a focus on optimization, flexibility, risk analysis and planning
• Act as the main liaison within Clinical Operations, Manufacturing, Quality, and external partners to support key tasks related to forecasting, planning, shipping, logistics, labeling, packaging and distribution of clinical materials and future commercial distribution
• Manage country logistics for shipping and importation and monitoring of enrolment, drop-out rates and actual supply needs
• Re-assess program needs to ensure forecasts are current and the impact on key raw materials, API and Drug Product
• Develop and formalize robust processes/procedures related to clinical & commercial supply chain activities in compliance with global regulations
• Manage processes for label creation and approvals, including translations for all countries and monitor drug expiry, and the appropriate inventory re-supply
• Responsible for the sourcing of comparators and matching placebo as needed
• Develop and support a vendor management process in cooperation with legal including vendor selection for each program/study, RFP, and SOWs with vendors
• Optimize the governance process with external vendors including inventory reports, budget and spending reviews
• Support of regulatory filings including IND and NDA submission information
• Monitor conformance to clinical supplies inventory management with Interactive Response Technology (IRT) standards when implemented

Knowledge/Skills/Abilities Required

• Complete and advanced understanding cGMP and cGCP requirements for clinical and commercial supply chains
• Strong leadership skills; demonstrated ability to build/lead a team and influence at all levels of the organization
• Strong analytical, problem solving and critical thinking skills
• Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform key updates and issues to executive leadership
• A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment, who communicates effectively with executive leaders and key external partners
• Experience in managing third-party clinical supply operations
• Experience in building and managing inventory management systems
• Experience in building and managing strong teams
• Comprehensive knowledge of IRT design for control of drug distribution and inventory management
• Strong understanding of IMP, QP, cGMP and cGCP practices and requirements
• Bachelor’s degree in scientific/pharmacy field
• A minimum 15+ years of leadership experience in Clinical Supply and Supply Chain operations required
• Available to travel if/when needed