Senior Manager, Clinical Supply Chain

Senior Manager, Clinical Supply Chain

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.

Position Summary

Reporting to the Executive Director, Clinical Supply Chain, the Senior Manager is responsible for 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 self-starter with the ability to work independently under minimal supervision.

Job Functions / Responsibilities

• Leads and establishes the overall strategy for Clinical Supply for all Mirum investigational drug products.
• Creates and maintains Clinical Supply forecasting models ensuring investigational material production is on par with corporate and financial goals, study enrollment, and business continuity.
• Leads the Clinical Supply program for investigation drug product inventory management and distribution in partnership with CMOs; evaluates drug utilization versus forecast considering country requirements and logistical timelines.
• Responsible for the oversight of Clinical Supply CMOs inclusive of selection (RFI), contract negotiations, financial review, daily operations, and the routine assessment of CMO performance via formal Business Reviews.
• Responsible for the management of global resupply strategies in IRT systems.
• Responsible for the creation, periodic review, and maintenance of all Clinical Supply SOPs.
• Accountable for initiating, overseeing, and resolving departmental deviations.
• 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.
• 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 :

Knowledge, Skills and Abilities :

The salary range for this position is $185,000 to $200,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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