Manager, Clinical Supply Chain
Mirum Pharmaceuticals, Inc.
August 19, 2026
Remote friendly (Foster City, CA)
United States
Operations
Job Functions/Responsibilities
- Leads and establishes the overall strategy for Clinical Supply for all investigational drug products.
- Creates and maintains Clinical Supply forecasting models to ensure production aligns with corporate/financial goals, study enrollment, and business continuity.
- Leads Clinical Supply inventory management and distribution with CMOs; evaluates utilization vs. forecast considering country requirements and logistical timelines.
- Oversees Clinical Supply CMOs (RFI/selection, contract negotiations, financial review, daily operations) and assesses performance via formal Business Reviews.
- Manages global resupply strategies in IRT systems.
- Partners with Clinical Operations, CMC, Quality, and other functions to execute the Clinical Supply strategy.
- Supports interactions with IRT vendors and Contract Research Organizations.
- Maintains study and depot-level accountability and reconciliation documentation for regulatory compliance and closeout.
- Archives Trial Master File documentation and Proof of Delivery (POD) documentation.
- Creates, periodically reviews, and maintains Clinical Supply SOPs.
- Initiates, oversees, and resolves departmental deviations; tracks and resolves temperature excursions.
- Supports preparation/review of regulatory and clinical documents (applications, amendments, protocols, briefing documents, Quality Technical Agreements, and responses to health authority inquiries).
Qualifications
- Degree in biological/life sciences, pharmacy, or medicine (or international equivalent); advanced degree desirable. Minimum 5 years in pharmaceutical industry and 3 years in Clinical Supply Chain.
- Proficient in daily Clinical Supply Chain operations (bulk management, distribution, maintaining study blinds across investigational products).
- Experienced with Clinical Supply Chain systems for inventory/resupply (Interactive Response Technology – IRT).
- Strong planning/organization; able to manage multiple projects with tight timelines.
- Excellent written and verbal communication.
- Experienced assisting as Clinical Supply Chain SME during Regulatory Inspections and Audits.
Skills/Knowledge
- Knowledge of import/export requirements; proactive cross-functional performance.
- Good knowledge of industry technology; drives forecasting/planning tied to protocol.
- Ability to build consensus and translate strategy into objectives/action plans; leadership.
- Clinical trials knowledge desirable.
Compensation
- Salary range: $130,000–$140,000 USD.
- Leads and establishes the overall strategy for Clinical Supply for all investigational drug products.
- Creates and maintains Clinical Supply forecasting models to ensure production aligns with corporate/financial goals, study enrollment, and business continuity.
- Leads Clinical Supply inventory management and distribution with CMOs; evaluates utilization vs. forecast considering country requirements and logistical timelines.
- Oversees Clinical Supply CMOs (RFI/selection, contract negotiations, financial review, daily operations) and assesses performance via formal Business Reviews.
- Manages global resupply strategies in IRT systems.
- Partners with Clinical Operations, CMC, Quality, and other functions to execute the Clinical Supply strategy.
- Supports interactions with IRT vendors and Contract Research Organizations.
- Maintains study and depot-level accountability and reconciliation documentation for regulatory compliance and closeout.
- Archives Trial Master File documentation and Proof of Delivery (POD) documentation.
- Creates, periodically reviews, and maintains Clinical Supply SOPs.
- Initiates, oversees, and resolves departmental deviations; tracks and resolves temperature excursions.
- Supports preparation/review of regulatory and clinical documents (applications, amendments, protocols, briefing documents, Quality Technical Agreements, and responses to health authority inquiries).
Qualifications
- Degree in biological/life sciences, pharmacy, or medicine (or international equivalent); advanced degree desirable. Minimum 5 years in pharmaceutical industry and 3 years in Clinical Supply Chain.
- Proficient in daily Clinical Supply Chain operations (bulk management, distribution, maintaining study blinds across investigational products).
- Experienced with Clinical Supply Chain systems for inventory/resupply (Interactive Response Technology – IRT).
- Strong planning/organization; able to manage multiple projects with tight timelines.
- Excellent written and verbal communication.
- Experienced assisting as Clinical Supply Chain SME during Regulatory Inspections and Audits.
Skills/Knowledge
- Knowledge of import/export requirements; proactive cross-functional performance.
- Good knowledge of industry technology; drives forecasting/planning tied to protocol.
- Ability to build consensus and translate strategy into objectives/action plans; leadership.
- Clinical trials knowledge desirable.
Compensation
- Salary range: $130,000–$140,000 USD.