Job Title: Clinical Supply Manager (Manager/Sr. Manager)

Work Location: Suffolk County, Massachusetts

Summary:

The Clinical Supply Manager is responsible for supporting the management of clinical supplies across multiple programs, collaborating with internal teams and external partners to ensure efficient planning, logistics, and inventory management of cold-chain drug products. This role requires expertise in clinical supply chain operations, GMP inventory management, and logistics, including import/export compliance and forecasting.

Responsibilities:

• Coordinate with various stakeholders and suppliers to achieve project goals, focusing on temperature-controlled shipping and inventory management for clinical drug products.
• Oversee domestic and international logistics, ensuring timely and compliant shipment of drug products and finished goods to relevant partners and depots.
• Review and verify global trade shipping documentation, including regulatory and customs paperwork, for accuracy and compliance.
• Ensure adherence to good manufacturing and distribution practices by following established policies and procedures.
• Plan, execute, and monitor shipments in collaboration with Quality Assurance, contract manufacturers, and logistics providers.
• Analyze shipment temperature data and address any temperature excursions during storage or transportation as needed.
• Collaborate within the supply chain team to implement process improvements and support ongoing enhancements.
• Monitor inventory levels and expiry dates across vendors, maintaining accurate records and compliance through controlled documentation systems.

Qualifications:

• Bachelor’s degree in a STEM field required.
• Minimum 4 years of relevant experience in clinical supply, logistics, or related field.
• Experience in end-to-end distribution, including temperature-controlled shipments and import/export documentation.
• Strong understanding of cGMP and familiarity with pharmaceutical development processes.
• Knowledge of import/export regulations, global trade compliance, and pro-forma invoice generation.
• Experience working with third-party CROs and CMOs.
• Excellent verbal and written communication skills.
• Ability to manage multiple workflows, resolve issues, and maintain thorough records.
• Proficiency with Microsoft Office applications (Word, Excel, Outlook) required; experience with Excel modeling or forecasting is a plus.
• APICS CSCP/CPIM certification and experience in a small company environment are advantageous.
• Highly motivated, decisive, and results-oriented with flexibility and creativity to thrive in a dynamic environment.

Published Category: Supply Chain & CMC