Senior Manager, Clinical Supply Planning and Inventory Management

Amylyx Pharmaceuticals•Cambridge, MA

14d•$144,000 - $162,000•Remote

About The Position

The Senior Manager of Clinical Supply Chain Planning develops, manages, and executes end-to-end clinical supply strategies for global clinical studies across multiple development phases. The role oversees clinical supply forecasting, vendor coordination, system 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 is remote within the United States, subject to state-based hiring restrictions. The employee is expected to travel to the company’s Cambridge, Massachusetts corporate location several times a year and attend other company events as needed. The remote work setting must support privacy, reliable internet access, phone use, and video conferencing. The estimated pay range is $144,000–$162,000 USD.

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 enables privacy, reliable internet access, phone use, and video conferencing.
Ability to travel to the Cambridge, MA corporate location several times a year and attend other company-related events as needed.

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.
Experience with genealogy tracking or recall best practices.

Responsibilities

Develop and manage clinical supply strategies and plans for assigned products, including raw starting materials, active pharmaceutical ingredients, bulk drug product, finished goods, investigational products, comparators, placebos, and ancillary materials.
Create, maintain, and communicate clinical supply forecasts using 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 confirm forecasted requirements can be met within study timelines and operational constraints.
Monitor clinical supply levels and proactively identify and mitigate supply constraints and risks that could affect study timelines.
Support clinical study closeouts by managing supply accountability, inventory reconciliation, and inspection-readiness preparations.
Represent clinical supply chain on study teams, operations meetings, and cross-functional project teams.
Partner with internal functions and external partners to align supply plans with clinical development objectives.
Work with Analytical Development on expiry extensions and dispositioning expired inventory at CMO locations.
Participate in protocol reviews and assess supply-chain impacts of study design changes.
Manage relationships with CMOs, clinical trial material vendors, depots, packaging and labeling vendors, IRT providers, logistics partners, and other 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 in 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 activities.
Identify supply-chain risks, lead contingency planning, and implement improvements to efficiency, scalability, compliance, and operational performance.
Track inventory at CMO locations and reconcile discrepancies; collect month-end inventory balance reports from partner locations for reconciliation with Amylyx Accounting.
Manage manual and system-driven inventory reporting and provide ad-hoc inventory analysis.
Support CMO inventory KPIs and continuous improvement.
Own master data in clinical supply-chain operating systems, including safety stock, item lead time, sourcing rules, and lot tracking.
Transact inventory movements in applicable supply-chain systems, such as IRT.
Collaborate across functions to establish clinical system requirements, complete user acceptance testing, and perform system transactions.