This position is located in Cambridge, MA!

We are seeking a motivated leader in clinical supply chain to build and lead the supply chain function. This Associate Director of Clinical Supply Chain will manage the clinical supply chain of multiple global clinical trials and contribute to the overall strategy of drug development at the company. The successful candidate needs to demonstrate a proven track record of managing CROs and CDMOs in developing and implementing clinical supply strategy to support Phase I to III global clinical trials, expanded access programs, and Investigator Sponsored Trials (IST). This position will report to the Head of CMC/QA.

• Work with CMC, Clinical Operations and Quality Assurance to develop supply chain to ensure uninterrupted clinical supplies.
• Create and update demand and supply forecasts in collaboration with Clinical Operations and CMC.
• Manage CDMO for packaging, labeling and distribution of clinical trial materials.
• Source investigational and commercial medicinal products to support clinical trials.
• Monitor inventory levels at depots and clinical sites and take preventive actions to avoid potential supply issues.
• Develop and manage IRT systems.
• Create and update SOPs for the clinical supply chain function.
• Serve as the supply chain representative in cross-functional project teams.

• B.S. with 10+ years of clinical supply chain experience in the bio/pharma industry.
• Excellent knowledge in demand and supply forecasts, packaging, and labeling, IRT system and global distribution and logistics.
• Experience in managing CROs and CDMOs.
• Familiar with cGMP, GDP and GCP requirements and relevant FDA and EU Regulations.
• A proven track record of implementing phase appropriate clinical supply chain strategies.
• Ability and track record of successfully working in cross-functional teams to progress projects as a representative of supply chain.
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
• A desire to be part of a highly innovative company aimed at helping patients with serious diseases.
• Effective verbal and written communication skills.