Sr. Clinical Supply Chain Manager

Responsibilities of the Sr. Clinical Supply Chain Manager:

• Will oversee drug management for multiple concurrent clinical trials from first-in- human studies through to pivotal studies, requiring in-depth understanding of GMPs, project management, IRT, drug accountability and supply forecasting.
• Proactively identifies areas for improvements and recommends solutions to emerging issues in an effective manner while taking into consideration risks and cost-effectiveness.
• Work collaboratively with CMC and QA to ensure trial supplies are appropriately supported including shelf life, inventories, country approvals.
• Lead the clinical label text creation, translation, approval process and printing activities for global clinical trials.
• Experience managing and working with Contract Packaging Vendor for scheduling and delivery of secondary packaging, labeling, IRT integration, distribution and return drug management activities.
• Working with vendors and/or CROs to contribute to the development within the IRT system requirements, user acceptance testing, and drug supply management.
• Responsible for Vendor management; including RFP review process, contracts/budget, performance accountability, invoice review and timeline management.

Requirements of the Sr. Clinical Supply Chain Manager:

• BA/BS degree, 5 + years of relevant experience in clinical supply chain management in the biopharmaceutical industry associated with complex global trials.
• Anticipates and proactively identifies, recommends creative solutions or escalates issues for project resolution.
• Must have experience working across functional areas within CMC and Clinical Ops.
• Experience with Phase 2 support is preferred.