Supply Chain Manager

Key Responsibilities

• Lead the planning and execution of clinical trial material supply for Elion’s global clinical studies, including forecasting, packaging, labeling, and distribution.
• Manage external label/pack and distribution vendors to ensure on-time delivery of high-quality clinical supplies.
• Develop, maintain, and execute an optimal supply strategy with proactive planning, appropriate lead-time, and replenishment quantities to ensure compliance and continuity of clinical supplies, including active, placebo, and comparator sourcing.
• Cook up cold chain sample and bulk GMP international shipments between end-to-end manufacturing sites, testing facilities, and warehouses.
• Coordinate with Interactive Response Technology (IRT) vendor throughout clinical trial duration, in collaboration with Clinical Operations.
• Support development and updates of pharmacy manuals for Phase I–III trials.
• Identify, assess, and proactively communicate supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity.
• Manage quality events, including deviations, investigations, CAPAs, specifications, and change controls.

Qualifications

• Bachelor’s degree in life sciences, business, or equivalent required.
• Minimum 5 years of related experience in the pharmaceutical or biotech industry with at least 3 years of direct experience in global clinical supply management supporting early through late stage clinical phases.
• Deep understanding of global GMP regulatory expectations and quality systems.
• Experience managing contract manufacturing sites and global supply chains.
• Demonstrated ability to work independently and professionally while managing multiple responsibilities.
• Proficient with Excel, Smartsheet, IRT, and inventory management systems.
• Strong communication, organizational, time management, interpersonal, conflict resolution, and problem-solving skills.
• Comfortable operating in a lean, fast-paced, and highly-collaborative, small or emerging biotech startup environment.
• Absolutely required to be based in Boston.