Associate Director, Clinical Supplies PM Lead

BioSpace; Cambridge (MA); Hybrid; USD 143,000 - 257,000; Full time

Benefits offered by this job

Healthcare coverage

Well-being resources

Paid time off and holidays

Savings and investment opportunities

Job summary

Moderna seeks an Associate Director, Clinical Supplies Project Management to lead end-to-end clinical supply activities, including demand planning, labeling, packaging, distribution, IRT UAT, and site activations.

Collaborate across therapeutic areas, mentor staff, and ensure timely delivery of drug supplies to sites while maintaining quality and regulatory compliance. The role emphasizes cross-functional leadership and process improvement.

Qualifications

• Eight+ years of clinical supply management experience in a clinical research environment.
• Bachelor's degree in a science-based subject (advanced degree preferred).
• Prior Cold Chain distribution experience required.
• IRT implementation, design, and management experience required.
• Experience with biopharmaceutical or pharmaceutical manufacturing preferred.
• Strong vendor relationships and ability to conduct business reviews.
• Working knowledge of ICH, FDA, IRB/IEC regulations and clinical protocol requirements.
• Proficiency with MS Office (Outlook, Word, Excel, PowerPoint) and SharePoint.

Responsibilities

• Identify resources required to manage programs and studies.
• Provide leadership and coaching to junior colleagues.
• Plan and manage budgets for programs.
• Drive best practices for supply logistics and related processes.
• Oversee inventory control, distribution, scheduling, and issue resolution.
• Coordinate labeling/packaging and drug supply shipments to depots and sites.
• Contribute to IRT requirements, UAT, and post go-live supply management.
• Forecast clinical supplies to meet program objectives and develop KPIs.
• Collaborate with CMC for production planning and distribution.
• Manage relationships with packaging organizations, IRT vendors, and CROs.
• Develop processes to improve clinical supplies operations and ensure quality.
• Coordinate labeling/packaging with CMC, clinical, and regulatory teams.
• Oversee vendor performance and drive improvement initiatives.
• Create pharmacy manuals and training materials for sites.

Skills

Leadership

Budget management

Project planning

Supply chain management

Vendor oversight

Cross-functional collaboration

Education

Bachelor's degree in science

Advanced degree preferred

Tools

MS Office

SharePoint

Job description

Moderna seeks an Associate Director, Clinical Supplies Project Management to lead end-to-end clinical supply activities, including demand planning, labeling, packaging, distribution, IRT UAT, and site activations.

Collaborate across therapeutic areas, mentor staff, and ensure timely delivery of drug supplies to sites while maintaining quality and regulatory compliance. The role emphasizes cross-functional leadership and process improvement.