Position located in Lexington, MA

Responsibilities of the Clinical Supply Chain Manager:

• Leads and provides direction around Supply Chain discussions in team meetings, having effective communication with customers and partners.
• Sets up the clinical supply chain strategy for studies and/or clinical portfolio of studies.
• Designs and implements labelling, packaging and supply strategies that not only meet the requirements of the study design, the clinical study sites and the relevant regulatory authorities, but also maximizes efficiency of supply.
• Manages, with input from CMC and Regulatory groups, the generation and approval of label texts, translations (where required) and label proofs.
• Produces a clinical supply agreement document documenting the agreed supply option providing details of the design, setup and how the supply chain will operate for responsible studies or group of studies.
• Seeks out expert input and support from cross functional groups.
• Understands and translates clinical protocol requirements into demand for study and where applicable aggregates demand for program of studies.

Requirements of the Clinical Supply Chain Manager:

• BS/BA or equivalent in operations, life sciences, or a health-related field.
• Minimum of 5 years of experience in the pharmaceutical/biotechnology industry, with a focus on clinical supply chain, clinical trial material management, or related areas.
• Strong understanding of cGMPs, FDA, and EU regulations governing clinical trials.
• Experience with primary and secondary packaging and labeling processes for investigational products.
• Strong understanding of cGMPs, FDA, and EU regulations governing clinical trials.