We are seeking a Clinical Supply Chain Manager to be part of our Supply Chain team.  This individual will manage day to day clinical supply activities for our early and late-stage programs. This position will design, develop, and implement the clinical supplies strategy to ensure appropriate continuous supply of material.  They will work closely with Clinical Operations, Quality Assurance, Regulatory Affairs, and CMOs. Strong cross-functional team leadership and project management skills are essential requirements of the role. 
 
Key Responsibilities:

• Coordinate primary and secondary packaging, labeling, distribution and return drug management activities with Contract Packaging Vendor.
• Responsible for all levels of studies, ranging from simple and complex, requiring in-depth understanding of GMPs, project management, IRT, medication management and/or use of advanced simulation tools.
• Responsible for scheduling and delivery of CTM including strategies for creating label design, randomization, packaging, labelling and distribution of clinical supplies.
• Operate closely with logistics function to proactively plan, document, and facilitate global cross border distribution strategies.
• Manage the day-to-day activities related to clinical studies including, confirmation of COA, COC, lot genealogy, IND/IMPD updates, IB and protocols.
• Interface with QA, RA, CMC/manufacturing to ensure trial supplies are appropriately supported including shelf life, quantities, country approvals and specifications.
• Maintain/track inventory of available clinical supplies and track expiration dates.
• Manage the procurement, distribution, packaging/labeling and clinical release of sponsor-sourced commercial study drug.
• Understand IRT (Interactive Response Technology) systems to obtain and manage inventory and shipments of IMP
• Work cross-functionally to help develop CTM label text, regulatory review, and translation activities
• Work with CMO to help facilitate QP release process
• Coordinate distribution, return and destruction of IMP activities with third-party vendor

Required Qualifications:

• 3 + years’ experience in clinical supply chain management in the biopharmaceutical industry associated with complex global trials.
• Candidate must have the ability to effectively prioritize and manage multiple projects and tasks.  
• Possess a flexible approach to problem solving and strong negotiations skills.
•  A team player, who listens effectively and invites response and discussion. 
• A collaborator who communicates in an open, clear, complete, timely and consistent manner.
• Proficiency with Microsoft PowerPoint, Excel and a general understanding of IRT systems and other inventory systems.  Understanding of GMP and GCP regulations.