Director, Clinical Supply Chain

About the Company Protego Bio is a clinical-stage biotechnology company based in San Diego, California, focused on developing first-in-class small-molecule therapeutics that target protein misfolding diseases. By restoring protein stability and function through novel pharmacological chaperones, Protego aims to transform the treatment of rare and systemic diseases with significant unmet medical need. Protego's lead program is being developed for AL amyloidosis and builds upon the clinically validated pharmacological chaperone approach pioneered by our cofounders, Dr. Jeffery W. Kelly and Dr. Richard Labaudinière, whose work led to the discovery and development of tafamidis for transthyretin amyloidosis (ATTR). About the job Protego Bio is seeking an experienced Director, Clinical supply chain (CSC) to join our CMC team. Reporting to the Chief Scientific Officer, the Director will own and execute the clinical supply chain for the global clinical trials as the company advances its lead AL amyloidosis program from proof-of-concept directly into a global pivotal study and on toward NDA/MAA submission. This is a senior, hands-on role requiring deep clinical supply chain expertise and the judgment to operate as the company’s primary supply chain expert within the CMC team. They will form a close partnership with the clinical operations team. The successful candidate will be a hands-on operator, working closely with the CMC team, while setting up the clinical supply chain for the program through registration and beyond. Primary Responsibilities Clinical supply management Global distribution, logistics, and inventory oversight — oversee initiation of global shipment, import/export requirements, depot and site-level inventory, expiry/stability monitoring, and temperature-excursion investigations, ensuring the correct drug product is in the right place, in compliant condition, at the right time. Drive alignment across Technical Operations, Clinical Operations, Quality Assurance, and Regulatory teams to clarify and communicate project priorities, progress, challenges, and resolution of issues . Provide alliance management oversight of service providers (CDMOs) to ensure work is delivered within contracted scope, schedule, and budget. Anticipate end-to-end supply forecasting and planning, develop study-level clinical trial material forecasts and integrated supply plans aligned with study execution strategy, including country-level and overall timelines; responsible for translating manufacturing (DS, DP, labeling, expiry) timelines and release plans into a robust clinical supply strategy . Provide IRT/IWRS system ownership, partner with clinical CRO on specification, user acceptance testing (UAT), and ongoing oversight of the Interactive Response Technology (IRT) system. Risk management and cross-functional coordination, identify supply chain risks (delays, shortages, temperature excursions, expiry) and lead contingency planning, partnering with Clinical Operations, Regulatory and Quality to keep CTM supply aligned with study execution and to maintain GxP/GDP compliance and TMF-ready documentation . Cross-Functional Collaboration Partner with the rest of the CMC team, Clinical Ops, Quality, Analytical Development, Clinical, Nonclinical, and Program Management to align development plans, timelines, and risk-mitigation strategies with global CMC regulatory expectations. Provide input on CMC and clinical supply chain decisions. Influence and align with the CSO and executive leadership on supply chain matters that have material program or financial impact. Contribute to a vendor and partner ecosystem that gives Protego the leverage of a larger organization while preserving the speed of a small one. Required Education, Experience, Skills, And Abilities Bachelor’s or Master’s degree in Supply Chain, Life Sciences, Pharmacy, Engineering, or a related scientific discipline with a minimum of five years of relevant pharmaceutical or biotechnology ind…

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