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Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSTION SUMMARY 

The Associate Director/Senior Manager will provide leadership and support in the planning, development, and execution of clinical supply chain activities for several clinical studies/programs in various phases. A successful candidate will demonstrate leadership ability, end-to-end clinical supply chain expertise (managing all aspects of clinical supplies in a global trial setting), be able to work independently and enjoy working in a dynamic, fast-paced environment during a period of significant growth.

• Review clinical protocols and translate clinical study requirements into demand for clinical trial materials (including medical devices and/or ancillaries as required) for supporting multiple global clinical studies
• Manage all clinical supply activities for on-time delivery, which includes demand forecasting, trial monitoring & resupply planning, packaging/distribution, Interactive Response Technology (IRT) set-up and distribution activities
• Strategically manage procurement, packaging, labeling, distribution, returns, reconciliation, destruction and storage tasks for all clinical trial materials (including medical devices and/or ancillary as required)
• Review and approve documentation related to packaging, labeling, and distribution of clinical trial materials. Maintain appropriate documentation in compliance with domestic and international regulations
• Author cGMP documentation including change controls, deviation reports, and SOP’s as required
• Manage clinical trial materials distribution and logistics for global clinical programs, including importing and exporting clinical supplies
• Support the procurement, labeling and distribution of comparators
• Work collaboratively with CMC, Clinical Operations, Quality Assurance and Regulatory Affairs to develop supply strategy to maximize supply efficiency, minimize waste, and develop risk mitigation plans to proactively identify any potential issues that may impact drug supply
• Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design & UAT testing
• Manage study closeouts and drug reconciliation at study end
• Develop and manage clinical supply budget and negotiate contracts with vendors

Qualifications:

Education:

• Requires a BS degree with a minimum of 5 years’ experience in a clinical supply chain management role in a biotechnology/pharmaceutical industry

Experience:

• Experience managing contract packaging and labeling organizations (strongly preferred)
• Experience with developing risk-based Clinical Trial Supplies management from early to late phases international clinical studies (double-blind, comparator)
• Manage vendor oversight activities and vendor performance to ensure high quality, cost effective execution of outsourced clinical supply activities
• Detailed understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements
• Detailed understanding of regulatory and Good Manufacturing Practices and Good Distribution Practices requirements for IMP supply and national/international transportation requirements for pharmaceutical materials
• Global distribution experience including working with QP, IXRS and regional depots
• Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient
• Excellent project management and communication skills
• 10 to 15% travel may be required (including international travel)

To apply, please send your resume to careers@mirumpharma.com.