Senior Specialist, Clinical Supply Chain

MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.POSTION SUMMARY Reporting to the Executive Director, Clinical Supply Chain, the Senior Specialist is responsible for supporting the senior team members in managing the global supply and distribution of investigational drug product for Mirum’s ongoing clinical trials inclusive of the oversight management of multiple Contract Manufacturing Organizations (CMOs) and distribution providers. The ideal candidate is a detailed oriented, self-starter, proactive, with the ability to work independently under minimal supervision. JOB FUNCTIONS/RESPONSIBILITIES Supports the development and execution of Clinical Supply strategies for all Mirum investigational drug products in collaboration with senior team members. Assists in creating and maintaining the Clinical Supply forecasting models to ensure investigational material production aligns with corporate and financial goals, study enrollment, and business continuity. Supports Clinical Supply program activities for investigational drug product inventory management and distribution in partnership with CMOs; evaluates drug utilization versus forecast considering country requirements and logistical timelines. Provides support for the oversight of Clinical Supply CMOs, including assisting in selection (RFI), contract negotiations, financial review, daily operations, and routine assessment of CMO performance via formal Business Reviews. Assists with the management of global resupply strategies in IRT systems. Interacts with the Clinical Operations, CMC, Quality, and other functions to ensure optimal execution of the Clinical Supply strategy for investigational drug products. Supports project-related interactions with IRT vendors and Contract Research Organizations. Maintains study and depot-level accountability and reconciliation documentation to support regulatory compliance and study closeout. Archives documentation on Trial Master Files as required. Archives Proof of Delivery (POD) documentation. Responsible for the creation, periodic review, and maintenance of all Clinical Supply SOPs. Accountable for initiating, overseeing, and resolving departmental deviations. Tracks and resolves temperature excursions. Supports the preparation and review of Mirum documentation including regulatory applications, clinical trial applications, routine amendments, protocols, briefing documents, Quality Technical Agreements, responses to health authority inquiries, and other documents as required. QUALIFICATIONS Education/Experience: Degree in biological or life sciences, pharmacy or medicine (or interna...