Amylyx Pharmaceuticals

Amylyx Pharmaceuticals

Senior Manager, Supply Planning, Clinical

Cambridge, MA · Senior

Sponsorship not specified$144k-$162kDetected 5 days ago
GCPProject ManagementStakeholder ManagementForecastingExcelSupply ChainLogisticsERPInventory ManagementRecruitingClinical TrialsGMPFDA RegulatoryExperimental DesignCommunicationCollaborationWritingMicrosoft OfficeNetSuiteDemand PlanningGxPBiostatisticsRegulatory Affairs

About the role

  • This role will oversee clinical supply forecasting, vendor coordination, systems transactions, compliance documentation, and risk mitigation to ensure uninterrupted supply of investigational product, placebos, and ancillary materials.
  • We anticipate hiring the Senior Manager, Supply Planning, Clinical in September 2026.

Responsibilities

  • Develop and manage clinical supply strategies and supply plans for assigned products, including RSMs, API, bulk drug product, finished goods, investigational product, comparators, placebos, and ancillary materials.
  • Create, maintain, and communicate clinical supply forecasts based on study enrollment assumptions, protocol design, adoption projections, manufacturing schedules, packaging and labeling plans, distribution needs, and inventory requirements.
  • Lead supply planning activities, including demand forecasting, inventory management, packaging, labeling, distribution, resupply strategies, and scenario planning.
  • Partner with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, CMC, External Manufacturing, Quality, Finance, and external partners to align supply plans with clinical development objectives.
  • Participate in protocol review activities and assess the supply chain impact of study design changes.
  • Manage relationships with CMOs, CTM vendors, depots, packaging and labeling vendors, IRT providers, logistics partners, and other external service providers.
  • Own or support applicable change controls, deviations, CAPAs, SOPs, and other quality documentation within the QMS.

Requirements

  • Bachelor's degree
  • 8+ years of experience in pharmaceutical or biotech supply chain operations, including clinical supply chain management.
  • Experience supporting global clinical trials across multiple phases of development.
  • Demonstrated experience in clinical supply planning, forecasting, inventory management, packaging, labeling, distribution, and logistics.
  • Strong understanding of GxP requirements, GMP/GCP expectations, clinical trial regulations, and quality systems.
  • Proficiency with clinical supply management systems, IRT systems, ERP platforms, QMS systems, Microsoft Office applications, Excel, and Smartsheet.
  • Ability to work effectively in a fast-paced, multi-disciplinary team environment.
  • Advanced degree, such as an MBA, MS, or related graduate degree.
  • Experience in a small to mid-sized biotech environment.
  • Experience supporting rare disease, neuroscience, or specialty pharmaceutical programs.

Nice to have

  • Preferred Requirements

Compensation

  • The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks.
  • Estimated Pay Range
  • $144,000 - $162,000 USD
  • Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.

Benefits

  • The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.

Equal opportunity

  • If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Visa & Work Authorization

  • that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related condition
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