Foster City

POSTION SUMMARY

Reporting to the Senior Director, Clinical Supply Chain, the Associate Director 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.
• Serves as the primary representative/subject matter expert (SME) during all inspections and clinical supply chain audits. 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.
• Management and oversight of Clinical Supply direct reports responsible for daily operations, distributions, and labeling activities (inclusive of consultants)

QUALIFICATIONS

Education/Experience:

• Degree in biological or life sciences, pharmacy or medicine (or international equivalent). An advanced degree is desirable. A minimum of 8 years in the pharmaceutical industry or relevant work experience and a minimum of 6 years in Clinical Supply Chain.
• Proficient in the daily management and operations of a Clinical Supply Chain inclusive of bulk management, distribution, and maintaining study blinds across multiple investigational products.
• Experienced with Clinical Supply Chain systems for inventory management and resupply (Interactive Response Technology – IRT).
• An experienced people manager both from a direct report and consultant relationship.
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
• Excellent communication skills both in writing and verbally.
• Experienced in assisting as the Clinical Supply Chain SME during Regulatory Inspections and Audits.

Knowledge, Skills and Abilities:

• Experienced with Clinical Supply Chain systems for inventory management and resupply (Interactive Response Technology – IRT).
• Knowledge of import / export requirements.
• Proactive in driving performance cross-functionally and fostering collaboration.
• Proficient /good knowledge of industry technology.
• Applies and drives Forecasting and Planning activity as it relates to protocol.
• Ability to build/drive internal team consensus.
• Translates broad strategies into specific objectives and action plans.
• Proficient in team and individual leadership.
• Knowledge and experience relating to clinical trials would be desirable.

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