Manager, Clinical Supply Management

Responsibilities

• Collaborate cross-functionally with Clinical Development, Manufacturing, Regulatory Affairs, and Quality Assurance to plan and execute IMP supply planning including labeling and packaging, utilization forecasting, inventory control, and international shipments and external depot management for Phase 1-4 international clinical studies
• Develop clinical supplies distribution plans based on program and study timelines, trial design, recruitment, geography, and manufacturing schedules
• Coordinate and manage clinical supplies forecasting and utilization to ensure on-time and reliable availability of IMP and required ancillary supplies in support of study execution
• Serve as the primary point of contact cross-functionally for clinical supplies planning, inventory monitoring, and distribution, and third-party service provider/depot selection and oversight
• Coordinate with Manufacturing Operations, Quality Assurance and Regulatory Affairs to ensure planned IMP release testing/re-testing, stability, expiry dates, labeling and packaging schedules align with program milestones, adjusting as necessary over the course of the program
• Develop and manage SOPs, work instructions, processes, systems, and forms governing clinical supplies management in alignment with industry standards and regulatory requirements
• Serve as internal subject matter expert on fit-for-purpose labeling and packaging design options best suited to meet study requirements
• Serve as liaison between Clinical Operations and Quality Assurance to manage IMP stability parameters, temperature deviation management, product complaints and associated investigations

Requirements

• 4-year college degree (relevant discipline preferred)
• Experience with electronic interactive response technologies for inventory management
• Experience with managing supply for clinical investigations of injectables and biologics
• Solid vendor management skills
• Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
• Thorough understanding of GMP, GCP, and ICH standards governing IMP labeling, packaging, and distribution
• Proficient in MS Office (Word, Excel, and PowerPoint)
• Able to work in a team or independently
• Effective interpersonal, written, and verbal communication skills
• Strong problem-solving capabilities
• Effectively collaborates with Study Team members
• Exceptional organizational skills with the ability to multi-task and prioritize
• Attention to detail
• Able to work with distributed team members and outside vendors

Preferred Experience

• In multiple therapeutic areas