Senior Manager, Supply Planning, Clinical
Amylyx Pharmaceuticals
August 12, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities
- Develop and manage end-to-end clinical supply strategies and plans for RSMs, API, bulk drug product, finished goods, investigational product, comparators, placebos, and ancillary materials.
- Create and communicate clinical supply forecasts (enrollment assumptions, protocol design, adoption projections, manufacturing schedules, packaging/labeling, distribution needs, inventory).
- Lead supply planning: demand forecasting, inventory management, packaging/labeling, distribution, resupply strategies, and scenario planning.
- Perform demand/supply analyses to meet study timelines and operational constraints.
- Monitor supply levels and proactively mitigate material supply constraints/risks.
- Serve as clinical supply chain representative on study and cross-functional teams; align supply plans with clinical development objectives.
- Assess supply impact of protocol design changes.
- Manage relationships with CMOs, CTM vendors, depots, packaging/labeling vendors, IRT providers, and logistics partners.
- Ensure GxP compliance; support change controls, deviations, CAPAs, SOPs, and quality documentation.
- Author/maintain supply chain SOPs; support technical writing for clinical pharmacy manuals.
- Support audits/inspections and implement process improvements.
Required Qualifications
- Bachelor’s degree.
- 5+ years in pharma/biotech supply chain operations, incl. clinical supply chain management.
- Experience with global, multi-phase clinical trials.
- Demonstrated clinical supply planning/forecasting, inventory, packaging/labeling, distribution/logistics.
- Vendor management experience (CMOs/depots/IRT/logistics/contract orgs).
- Strong GxP/GMP/GCP and quality system knowledge.
- Proficiency with IRT systems, ERP platforms, QMS systems, MS Office/Excel, Smartsheet.
- Strong project, analytical, communication, collaboration, and stakeholder management.
Preferred Qualifications
- MBA/MS or related graduate degree; small/mid-sized biotech experience.
- Rare disease/neuroscience/specialty pharma experience.
- Experience with Suvoda, NetSuite, Veeva or similar platforms; APICS/ASCM or PMP.
- Technical writing experience; global supply network/genealogy tracking/recall readiness.
Compensation
- Estimated pay range: $144,000–$162,000 USD.
- Develop and manage end-to-end clinical supply strategies and plans for RSMs, API, bulk drug product, finished goods, investigational product, comparators, placebos, and ancillary materials.
- Create and communicate clinical supply forecasts (enrollment assumptions, protocol design, adoption projections, manufacturing schedules, packaging/labeling, distribution needs, inventory).
- Lead supply planning: demand forecasting, inventory management, packaging/labeling, distribution, resupply strategies, and scenario planning.
- Perform demand/supply analyses to meet study timelines and operational constraints.
- Monitor supply levels and proactively mitigate material supply constraints/risks.
- Serve as clinical supply chain representative on study and cross-functional teams; align supply plans with clinical development objectives.
- Assess supply impact of protocol design changes.
- Manage relationships with CMOs, CTM vendors, depots, packaging/labeling vendors, IRT providers, and logistics partners.
- Ensure GxP compliance; support change controls, deviations, CAPAs, SOPs, and quality documentation.
- Author/maintain supply chain SOPs; support technical writing for clinical pharmacy manuals.
- Support audits/inspections and implement process improvements.
Required Qualifications
- Bachelor’s degree.
- 5+ years in pharma/biotech supply chain operations, incl. clinical supply chain management.
- Experience with global, multi-phase clinical trials.
- Demonstrated clinical supply planning/forecasting, inventory, packaging/labeling, distribution/logistics.
- Vendor management experience (CMOs/depots/IRT/logistics/contract orgs).
- Strong GxP/GMP/GCP and quality system knowledge.
- Proficiency with IRT systems, ERP platforms, QMS systems, MS Office/Excel, Smartsheet.
- Strong project, analytical, communication, collaboration, and stakeholder management.
Preferred Qualifications
- MBA/MS or related graduate degree; small/mid-sized biotech experience.
- Rare disease/neuroscience/specialty pharma experience.
- Experience with Suvoda, NetSuite, Veeva or similar platforms; APICS/ASCM or PMP.
- Technical writing experience; global supply network/genealogy tracking/recall readiness.
Compensation
- Estimated pay range: $144,000–$162,000 USD.