What You’ll Do: We are searching for a highly motivated Manager Clinical Supply Chain. Reporting to the Senior Director, Global Supply Chain, the desired candidate will be responsible for managing investigational drug supplies for global clinical trials. The candidate will be responsible for all aspects of clinical supply management including forecasting, labeling distribution, monitoring inventory and IRT vendor oversight.

Responsibilities:

• Responsible for all aspects of clinical supply management including forecasting, packaging, labeling, distribution, inventory monitoring and IRT vendor oversight
• Collaborate with clinical operations to forecast demand
• Work closely with CMC team to develop comprehensive supply plans taking into account anticipated demand and shelf-life limitations
• Manage external CDMO for packaging and labeling operations
• Review and approve pre and post-production documentation of clinical supplies
• Provide logistical support for global shipments of clinical trial material shipments as well as drug substance and drug product as needed
• Manage Interactive Response Technology (IRT) systems from initial design to implementation and management, with assistance from the team
• Manage clinical label design and approval
• Assist in establishing clinical supply processes and associated SOPs

Qualifications:

• Bachelor's degree in business administration, supply chain management or related discipline
• 4+ years clinical supply chain experience in pharmaceutical or biotech industry
• Experience virtually managing CMO/CROs
• Experience with CTM planning
• Experience in managing IRT vendors
• Solid understanding of cGMPs, clinical operations, and development processes
• Detailed oriented with ability to work in a fast-changing environment

Location: This is a hybrid position with three days on site at our office in Burlington, MA.