The Opportunity

The Senior Manager of Clinical Supply Chain Planning will be responsible for developing, managing, and executing end-to-end clinical supply strategies in support of global clinical studies across multiple phases of development. 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. The position requires close collaboration with Clinical Operations, CMC, External Manufacturing, Quality, Regulatory Affairs, Finance, depots, IRT providers, packaging and labeling vendors, logistics partners, and other cross-functional stakeholders.

Responsibilities

Clinical Supply Planning and Execution

• Build 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.
• Conduct demand and supply analyses to ensure forecasted requirements can be fulfilled within study timelines and operational constraints.
• Monitor clinical supply levels and proactively identify and mitigate material supply constraints or risks that may impact study timelines.
• Support clinical study closeout(s) by managing supply accountability, inventory reconciliation, and inspection readiness preparations.

Cross-Functional and Vendor Collaboration

• Serve as the clinical supply chain representative on clinical study teams, internal and external operations meetings, and cross-functional project teams.
• 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.
• Partner with Analytical Development to manage expiry extensions and dispositioning of expired inventory at CMO locations.
• 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.
• Create, track, and manage purchase orders and change orders for supply chain planning-related activities.

Quality, Compliance, and Continuous Improvement

• Ensure clinical supply activities comply with applicable GxP regulations, company policies, clinical trial regulations, and industry best practices.
• Own or support applicable change controls, deviations, CAPAs, SOPs, and other quality documentation within the QMS.
• Author and maintain supply chain SOPs and support technical writing for clinical pharmacy manuals and related controlled documents.
• Support internal and external audits, inspections, and inspection readiness preparations.
• Identify supply chain risks, lead contingency planning, and implement process improvements to enhance efficiency, scalability, compliance, and operational performance.

Inventory Management

• Track inventory at all CMO (contract manufacturing organization) locations and reconcile inventory discrepancies. Collect month-end inventory balance reports for all Amylyx partner locations to reconcile with Amylyx Accounting team at each month-end.
• Manage both manual and system-driven inventory reporting.
• Provide ad-hoc inventory analysis. Experience with genealogy tracking/recall best practices is a plus.
• Support CMO inventory KPI’s to drive continuous improvement.
• Own master data in clinical supply chain operating systems to maintain accurate safety stock inventory, item lead time, sourcing rules, lot tracking, etc.
• Transact inventory movements in applicable supply chain operating systems (ex. IRT)
• Collaborate cross functionally to establish user clinical system requirement specs, complete UAT, and perform system transactions.

Required Qualifications

• 5+ years of relevant experience in the Pharmaceutical Industry; or a BS degree and minimum 4+ years of relevant experience; or a MS degree and minimum 3 years of relevant experience.
• Demonstrated experience in clinical supply planning, forecasting, inventory management, packaging, labeling, distribution, and logistics.
• Experience managing external vendors, CMOs, depots, IRT providers, logistics partners, and other contract organizations.
• 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.
• Strong project management, organizational, analytical, communication, presentational, collaboration, and stakeholder management skills.
• Ability to work effectively in a fast-paced, multi-disciplinary team environment.

Preferred Requirements

• Experience in a small to mid-sized biotech environment.
• Experience supporting rare disease, neuroscience, or specialty pharmaceutical programs.
• Experience with Suvoda, NetSuite, Veeva, or similar clinical supply, ERP, or QMS platforms.
• Technical writing experience related to SOPs, clinical pharmacy manuals, or other controlled documents.
• Experience with global supply networks, international distribution, genealogy tracking, and recall-readiness best practices.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska and Hawaii.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.