Senior Specialist, Clinical Supply Chain
Mirum Pharmaceuticals, Inc.
August 20, 2026
Remote friendly (Foster City, CA)
United States
Operations
Position Summary:
Reporting to the Executive Director, Clinical Supply Chain, the Senior Specialist supports global supply and distribution of investigational drug product for ongoing clinical trials, including oversight of multiple Contract Manufacturing Organizations (CMOs) and distribution providers.
Job Functions/Responsibilities:
- Support development and execution of Clinical Supply strategies for investigational drug products.
- Create and maintain Clinical Supply forecasting models to align production with corporate/financial goals, study enrollment, and business continuity.
- Support inventory management and distribution with CMOs; evaluate utilization vs. forecast considering country requirements and logistical timelines.
- Support oversight of CMOs (RFI, contract negotiations, financial review, daily operations, performance assessment via Business Reviews).
- Assist with global resupply strategies in IRT systems.
- Coordinate with Clinical Operations, CMC, Quality, and other functions to execute Clinical Supply strategy.
- Support interactions with IRT vendors and Contract Research Organizations.
- Maintain study and depot-level accountability/reconciliation documentation for regulatory compliance and study closeout.
- Archive Trial Master File documentation and Proof of Delivery (POD) documentation.
- Create, periodically review, and maintain Clinical Supply SOPs.
- Initiate, oversee, and resolve departmental deviations; track and resolve temperature excursions.
- Support preparation/review of regulatory and clinical trial documents (applications, amendments, protocols, briefing docs, QTA responses, health authority responses, etc.).
Qualifications:
Education/Experience:
- Degree in biological/life sciences, pharmacy, or medicine (or international equivalent).
- 5+ years pharmaceutical industry experience; 3+ years in Clinical Supply Chain.
- Clinical Supply Chain operations experience (bulk management, distribution, maintaining study blinds).
- Experience with IRT inventory management and resupply.
- Assist during Regulatory Inspections and Audits.
Knowledge/Skills:
- Knowledge of import/export requirements.
- Strong planning/organizational skills; ability to manage multiple projects with tight timelines.
- Excellent written and verbal communication.
- Proactive cross-functional collaboration; good industry technology knowledge.
- Forecasting/Planning tied to protocol; ability to build consensus; knowledge of clinical trials desirable.
Compensation:
- Salary range: $115,000 to $125,000 USD.
Reporting to the Executive Director, Clinical Supply Chain, the Senior Specialist supports global supply and distribution of investigational drug product for ongoing clinical trials, including oversight of multiple Contract Manufacturing Organizations (CMOs) and distribution providers.
Job Functions/Responsibilities:
- Support development and execution of Clinical Supply strategies for investigational drug products.
- Create and maintain Clinical Supply forecasting models to align production with corporate/financial goals, study enrollment, and business continuity.
- Support inventory management and distribution with CMOs; evaluate utilization vs. forecast considering country requirements and logistical timelines.
- Support oversight of CMOs (RFI, contract negotiations, financial review, daily operations, performance assessment via Business Reviews).
- Assist with global resupply strategies in IRT systems.
- Coordinate with Clinical Operations, CMC, Quality, and other functions to execute Clinical Supply strategy.
- Support interactions with IRT vendors and Contract Research Organizations.
- Maintain study and depot-level accountability/reconciliation documentation for regulatory compliance and study closeout.
- Archive Trial Master File documentation and Proof of Delivery (POD) documentation.
- Create, periodically review, and maintain Clinical Supply SOPs.
- Initiate, oversee, and resolve departmental deviations; track and resolve temperature excursions.
- Support preparation/review of regulatory and clinical trial documents (applications, amendments, protocols, briefing docs, QTA responses, health authority responses, etc.).
Qualifications:
Education/Experience:
- Degree in biological/life sciences, pharmacy, or medicine (or international equivalent).
- 5+ years pharmaceutical industry experience; 3+ years in Clinical Supply Chain.
- Clinical Supply Chain operations experience (bulk management, distribution, maintaining study blinds).
- Experience with IRT inventory management and resupply.
- Assist during Regulatory Inspections and Audits.
Knowledge/Skills:
- Knowledge of import/export requirements.
- Strong planning/organizational skills; ability to manage multiple projects with tight timelines.
- Excellent written and verbal communication.
- Proactive cross-functional collaboration; good industry technology knowledge.
- Forecasting/Planning tied to protocol; ability to build consensus; knowledge of clinical trials desirable.
Compensation:
- Salary range: $115,000 to $125,000 USD.