Senior Clinical Supplies Program Manager

Moderna; Cambridge (MA); On-site; USD 131,000 - 209,000; Full time

Benefits offered by this job

Annual discretionary bonus

Healthcare benefits

Paid time off

Job summary

Moderna is seeking a Sr. Manager, Clinical Supplies Project Management to oversee the clinical drug supply planning, labeling, packaging, and distribution across programs. You will coordinate with CMC, IRT, CROs, and vendors to meet study timelines and quality standards.

This role emphasizes collaboration across therapeutic areas, rigorous forecasting, KPI development, and regulatory compliance. A strong background in cold-chain packaging and IRT with 5–8 years in clinical supply is preferred,

Qualifications

• Minimum 5–8 years of clinical drug supply management experience in a clinical research environment.
• Bachelor’s degree in a science-based subject.
• Experience with cold-chain packaging, labeling, and distribution.
• IRT design and management experience.
• Clinical Supplies Planning and Forecasting expertise.
• Experience with Clinical Supply Inventory Management systems.
• Vendor management experience and cross-functional collaboration.
• Knowledge of ICH, FDA, IRB/IEC regulations and clinical research requirements.
• MS Office skills (Outlook, Word, Excel, PowerPoint, SharePoint).

Responsibilities

• Manage logistics to support labeling, packaging and shipment of clinical drug supplies to depots and sites.
• Participate in business review meetings with third-party drug supply vendors.
• Oversee IRT requirements, user acceptance testing, and management.
• Lead Clinical Supplies Planning and Forecasting to meet program objectives.
• Develop and compile KPIs (metrics) for performance monitoring.
• Coordinate inventory control, scheduling, issue resolution, and vendor oversight.
• Collaborate with CMC for Production Planning and Distribution; forecast drug supply needs.
• Ensure SOP compliance and implement industry best practices.
• Work with CMC and clinical groups on Master Production Schedule to meet trial timelines.
• Maintain vendor relationships and ensure quality, on-time delivery, and improvements.
• Develop pharmacy manual and drug supply training materials for sites.

Skills

Clinical supply management

Vendor management

Cross-functional collaboration

Forecasting

Regulatory knowledge

MS Office

Education

Bachelor's degree in a science-based field

Tools

MS Office Suite

Job description

Moderna is seeking a Sr. Manager, Clinical Supplies Project Management to oversee the clinical drug supply planning, labeling, packaging, and distribution across programs. You will coordinate with CMC, IRT, CROs, and vendors to meet study timelines and quality standards.

This role emphasizes collaboration across therapeutic areas, rigorous forecasting, KPI development, and regulatory compliance. A strong background in cold-chain packaging and IRT with 5–8 years in clinical supply is preferred,