Manager, Clinical Supply Chain - Planning
Alnylam Pharmaceuticals
3 days ago
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities:
- Build and maintain clinical supply forecasts by translating protocol assumptions (enrollment rates, dosing schedules, country footprint) into study-level demand; continuously update as trials progress.
- Develop integrated CFG supply plans aligning forecasted demand with inventory strategy to ensure adequate supply while minimizing overage, expiry risk, and waste.
- Anticipate and quantify future supply risks (assumptions, scenarios, constraints) and recommend mitigations/tradeoffs before they impact trial continuity.
- Collaborate with Global Planning and CMC to translate demand forecasts into manufacturing, packaging, and release plans, aligned on lead times, capacity constraints, and material availability.
- Validate and refine forecasting assumptions with Program Development/Clinical Teams as study designs, enrollment dynamics, and protocols evolve.
- Partner with Finance to connect demand forecasts to long-range budget planning and scenario modeling.
Qualifications:
- B.Sc. in a scientific field, Supply Chain Management, or related field.
- 4+ years of direct Clinical Supply Chain experience globally.
- Knowledge of GMP/GxP/GCP and global regulatory requirements (FDA, EU, etc.).
- Strong clinical supply chain knowledge (packaging, labeling, inventory, global distribution) for accurate forecasting.
- Understanding of clinical trial operations and the drug development lifecycle.
- Strong analytical/problem-solving skills; ability to track forecast accuracy and inventory performance.
- Excellent communication and stakeholder management to present forecasts, risks, and trade-offs.
- Proven ability to operate in a fast-paced, matrixed environment managing multiple studies.
- Proficient in MS Office (Excel, PowerPoint, Visio, Project, etc.).
- Build and maintain clinical supply forecasts by translating protocol assumptions (enrollment rates, dosing schedules, country footprint) into study-level demand; continuously update as trials progress.
- Develop integrated CFG supply plans aligning forecasted demand with inventory strategy to ensure adequate supply while minimizing overage, expiry risk, and waste.
- Anticipate and quantify future supply risks (assumptions, scenarios, constraints) and recommend mitigations/tradeoffs before they impact trial continuity.
- Collaborate with Global Planning and CMC to translate demand forecasts into manufacturing, packaging, and release plans, aligned on lead times, capacity constraints, and material availability.
- Validate and refine forecasting assumptions with Program Development/Clinical Teams as study designs, enrollment dynamics, and protocols evolve.
- Partner with Finance to connect demand forecasts to long-range budget planning and scenario modeling.
Qualifications:
- B.Sc. in a scientific field, Supply Chain Management, or related field.
- 4+ years of direct Clinical Supply Chain experience globally.
- Knowledge of GMP/GxP/GCP and global regulatory requirements (FDA, EU, etc.).
- Strong clinical supply chain knowledge (packaging, labeling, inventory, global distribution) for accurate forecasting.
- Understanding of clinical trial operations and the drug development lifecycle.
- Strong analytical/problem-solving skills; ability to track forecast accuracy and inventory performance.
- Excellent communication and stakeholder management to present forecasts, risks, and trade-offs.
- Proven ability to operate in a fast-paced, matrixed environment managing multiple studies.
- Proficient in MS Office (Excel, PowerPoint, Visio, Project, etc.).