Amylyx
Senior Manager, Clinical Supply Planning and Inventory Management
Cambridge, MA. Posted 18 days ago
The role
The Senior Manager of Clinical Supply Chain Planning will develop, manage, and execute end-to-end clinical supply strategies for global clinical studies. This role involves overseeing forecasting, vendor coordination, inventory management, and risk mitigation to ensure uninterrupted supply of investigational products and materials.
What you will do
- Build and manage clinical supply strategies and supply plans for assigned products.
- Create, maintain, and communicate clinical supply forecasts.
- Lead supply planning activities including demand forecasting and inventory management.
- Conduct demand and supply analyses to ensure requirements are fulfilled.
- Monitor clinical supply levels and mitigate material supply constraints.
- Support clinical study closeout through supply accountability and inventory reconciliation.
- Serve as the clinical supply chain representative on clinical study teams.
- Partner with cross-functional teams to align supply plans with clinical development objectives.
- Manage relationships with CMOs, vendors, depots, and logistics partners.
- Track inventory at CMO locations and reconcile discrepancies.
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.
- Access to a work setting that enables meeting all role requirements including privacy, reliable internet access, phone, and ability to video conference.
Nice to have
- 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.
Benefits
- Competitive base pay
- Annual performance-based bonuses
- Equity awards
- Comprehensive benefits package
Before you apply
- Unable to hire employees who reside and/or work in certain states.
- Currently not considering applicants from Alaska and Hawaii.
About the company
Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The company has a mission to treat diseases with high unmet needs through rigorous science and an experienced team.