Senior Manager, Supply Planning, Clinical

Amylyx Pharmaceuticals•Cambridge, MA

29d•$144,000 - $162,000•Remote

About The Position

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.

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.
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.

Nice To Haves

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.
Experience with Suvoda, NetSuite, Veeva, or similar clinical supply, ERP, or QMS platforms.
APICS/ASCM, PMP, or related certification.
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

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.
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.
Serve as the clinical supply chain representative on clinical study teams, internal 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.
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.
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.