Remote Senior Manager, Clinical Supply Planning

Amylyx Pharmaceuticals; Cambridge (MA); On-site; USD 144,000 - 162,000; Full time

Job summary

Amylyx Pharmaceuticals is seeking a Senior Manager of Clinical Supply Chain Planning to lead end-to-end clinical supply strategies for global studies. You will forecast demand, coordinate with CMOs and depots, and ensure uninterrupted supply of investigational products, placebos, and ancillary materials.

You will collaborate with Clinical Operations, Regulatory, Quality, and External Manufacturing to align supply plans with development objectives, mitigate risks, and drive continuous improvement

Qualifications

• Bachelor’s degree or higher in a related field.
• 8+ years of pharmaceutical/biotech supply chain experience including clinical supply.
• Experience supporting global clinical trials across multiple phases.
• Experience managing external vendors, CMOs, depots, IRT providers, logistics partners.
• Strong understanding of GxP, GMP/GCP expectations, and quality systems.
• Proficiency with clinical supply management systems, ERP/QMS platforms, and MS Office.

Responsibilities

• Develop and manage clinical supply strategies and plans for products, including API, bulk drug product, and finished goods.
• Create, maintain, and communicate clinical supply forecasts based on enrollment and protocol designs.
• Lead forecasting, inventory management, packaging, labeling, distribution, and resupply strategies.
• Monitor supply levels and identify risks to mitigate impact on study timelines.
• Collaborate with cross-functional teams to align supply plans with development objectives.
• Manage relationships with CMOs, depots, packaging vendors, IRT providers, and logistics partners.
• Support change controls, deviations, CAPAs, SOPs, and quality documentation.

Skills

Clinical supply planning

Forecasting

Vendor management

GxP/regulatory

Project management

Cross-functional collaboration

Education

Bachelor’s degree

Tools

Smartsheet

ERP systems

QMS

MS Excel

NetSuite

Veeva

Job description

Amylyx Pharmaceuticals is seeking a Senior Manager of Clinical Supply Chain Planning to lead end-to-end clinical supply strategies for global studies. You will forecast demand, coordinate with CMOs and depots, and ensure uninterrupted supply of investigational products, placebos, and ancillary materials.

You will collaborate with Clinical Operations, Regulatory, Quality, and External Manufacturing to align supply plans with development objectives, mitigate risks, and drive continuous improvement