Senior Manager, Clinical Supply Chain

Role Summary

Senior Manager, Clinical Supply Chain responsible for leading clinical supply chain activities in global Phase 1 and Phase 3 trials for the lead oncology asset, with oversight to ensure safe, efficient, and compliant delivery of investigational therapy to patients worldwide. Hybrid role based in Boston with three in-office days per week.

Responsibilities

• Develop, own, and execute end-to-end clinical supply chain strategies for Phase 1 and Phase 3 global oncology trials, aligned with clinical development objectives.
• Create, maintain, and refine supply and demand forecasts; collaborate with Clinical Operations, CMC, Quality, and Regulatory Affairs to ensure robust supply and minimize waste/obsolescence.
• Develop and manage the clinical supply budget, forecasting for IMP, comparator drugs, ancillary supplies, and vendor-related costs.
• Drive vendor performance and partnerships through KPIs, regular business reviews, and proactive issue resolution.
• Oversee lifecycle of clinical trial materials (IMP, placebo, comparators) from manufacturing release to packaging, labeling, distribution, site inventory, final reconciliation, and destruction.
• Manage cold chain integrity for temperature-sensitive products and lead investigations of temperature excursions in quality/regulatory compliance.
• Coordinate global distribution, manage central/regional depots, and ensure compliance with international import/export regulations for clinical trial materials.
• Author/approve country-specific label text; oversee packaging/labeling campaigns; review/approve batch records at contract vendors.
• Serve as primary owner of Interactive Response Technology (IRT); develop URS, execute UAT, and oversee randomization and drug supply management modules for trials.
• Develop, author, and implement SOPs for all clinical supply chain activities to ensure consistency, efficiency, and compliance.
• Ensure compliance with cGMP, GCP, GDP, and global regulatory requirements for clinical trial materials.
• Maintain audit-ready documentation (batch records, shipping docs, accountability logs, temperature data) for TMF and act as SME during audits/regulatory inspections.

Qualifications

• Bachelor’s degree in Life Sciences, Supply Chain Management, Pharmacy, or related field; advanced degree preferred.
• 5–8+ years of experience in clinical supply chain management within biotech/pharma.
• Hands-on experience managing supply chains for Phase 1/2 and Phase 3 global blinded trials.
• Experience managing a network of external vendors (CMOs, packagers, labelers, depots).
• Experience with IRT systems, including URS development, UAT, and post-launch management for complex studies.
• Strong understanding of cGMP, GCP, GDP, and global clinical trial regulations, including IMP labeling and international import/export.
• Experience with cold-chain logistics (2-8°C and frozen) for biologics or temperature-sensitive products.
• Familiarity with ERP or advanced planning systems (e.g., Oracle, SAP, Kinaxis) is a plus.
• Ability to adapt in a fast-paced, cross-functional environment with evolving priorities.