Senior Manager, Clinical Supply Planning and Inventory Management

Amylyx Pharmaceuticals•Cambridge, MA

13d•Remote

About The Position

The Senior Manager of Clinical Supply Chain Planning develops, manages, and executes end-to-end clinical supply strategies supporting global clinical studies across multiple phases of development. The role oversees clinical supply forecasting, vendor coordination, systems transactions, compliance documentation, and risk mitigation to help ensure uninterrupted supply of investigational products, placebos, and ancillary materials. It collaborates closely with Clinical Operations, CMC, External Manufacturing, Quality, Regulatory Affairs, Finance, depots, IRT providers, packaging and labeling vendors, logistics partners, and other stakeholders. The position manages supply plans and forecasts, demand and inventory analyses, packaging, labeling, distribution, resupply, and scenario planning. It monitors supply levels, mitigates risks, supports study closeout and inspection readiness, and coordinates with internal teams and external vendors. It also ensures compliant clinical supply activities, maintains quality documentation and SOPs, supports audits, and drives process improvements. Inventory responsibilities include tracking and reconciling inventory across CMO and partner locations, month-end reporting, inventory analysis, maintaining operating-system master data, and processing inventory transactions. The role is remote within the United States, subject to state restrictions, with travel to Cambridge, Massachusetts several times a year and attendance at other company events as needed.

Requirements

At least 5 years of relevant pharmaceutical industry experience; alternatively, a BS degree and at least 4 years of relevant experience, or an MS degree and at least 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, presentation, collaboration, and stakeholder management skills.
Ability to work effectively in a fast-paced, multidisciplinary team environment.
Access to a remote work setting that supports privacy, reliable internet, phone use, and video conferencing.
Ability to travel to the corporate location in Cambridge, Massachusetts several times a year and attend other company-related events as requested.

Nice To Haves

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.

Responsibilities

Build and manage clinical supply strategies and supply plans for assigned products and materials, including RSMs, API, bulk drug product, finished goods, investigational product, comparators, placebos, and ancillary materials.
Create, maintain, and communicate clinical supply forecasts based on enrollment assumptions, protocol design, adoption projections, manufacturing schedules, packaging and labeling plans, distribution needs, and inventory requirements.
Lead demand forecasting, inventory management, packaging, labeling, distribution, resupply strategies, and scenario planning.
Analyze demand and supply to ensure forecasted requirements can be fulfilled within study timelines and operational constraints.
Monitor clinical supply levels and proactively identify and mitigate constraints or risks that could affect study timelines.
Support clinical study closeouts by managing supply accountability, inventory reconciliation, and inspection-readiness preparation.
Represent clinical supply chain on clinical study teams, internal and external operations meetings, and cross-functional project teams.
Partner with internal functions and external partners to align supply plans with clinical development objectives.
Partner with Analytical Development to manage expiry extensions and disposition expired inventory at CMO locations.
Participate in protocol reviews 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 activities.
Ensure clinical supply activities comply with applicable GxP regulations, company policies, clinical trial regulations, and industry best practices.
Own or support 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 other controlled documents.
Support internal and external audits, inspections, and inspection-readiness preparations.
Identify supply chain risks, lead contingency planning, and implement process improvements to improve efficiency, scalability, compliance, and operational performance.
Track inventory at CMO locations and reconcile inventory discrepancies.
Collect month-end inventory balance reports for Amylyx partner locations and reconcile them with the Amylyx Accounting team.
Manage manual and system-driven inventory reporting and provide ad-hoc inventory analysis.
Support CMO inventory KPIs to drive continuous improvement.
Own master data in clinical supply chain operating systems, including safety stock inventory, item lead times, sourcing rules, and lot tracking.
Transact inventory movements in applicable supply chain operating systems, such as IRT.
Collaborate cross-functionally to establish clinical system user requirement specifications, complete UAT, and perform system transactions.