Director, Global Clinical Supply Chain

Job Summary: 

The Director of Global Clinical Supply Chain will report to the Sr. Director of Global Supply Chain and is part of CMC Process Development &Technical Operations.

The Director, Global Clinical Supply Chain possesses a good understanding of Clinical supply management, CMC, regulatory, and project management terminology and demonstrates effective communication skills. The Director of Global Clinical Supply Chain collects and assesses information from various sources including cross-functional teams, systems, tools, and communication with functional leads. The Director of Global Clinical Supply Chain is responsible for the successful execution of supply chain management for clinical trials This role provides triage support to the rapid start-up of CDMOs, CROs to enable clinical study initiation at clinical sites, and ongoing support of the sites including returns and reconciliation.

The Director, Global supply chain, partners with the Clinical Operations group and CMC group to ensure the continuous supply of Investigational Medicinal Product (IMP) for company trials. Provide oversight of packaging and labeling vendors, distribution, and is administering Interactive Response Technology (IRT) to supply study drugs to global clinical trials using sound supply chain techniques.

Key Responsibilities: 

• Managing and executing overall Project Delivery through coordination of CMC efforts assigned to the entire project team (including but not limited to CMC, Supply Chain, Legal, Procurement, Regulatory, Clinical Development, and Clinical Operations).
• Develops Inventory management plans for complex supply chain solutions
• Interprets clinical synopsis and protocols and creates clinical forecast
• Executes supply chain inventory management in partnership with Clinical operations.
• Proactively identifies potential supply chain issues, provides analysis, and recommends solutions
• Performs study closeout activities including returned good reconciliation, inventory destruction processing, and file archiving
• Manage the inventory and shipment logistics of all products and associated samples. Ensures temperature excursion process is executed as required
• Liaison with Suppliers to manage relationships and drive triage level activities that require diligent focus with rapid start-up, the resolution to issues, and response to questions related to CMC projects
• Provides recommendations on packaging design, distribution, and blinding strategy, plans, and manages the execution of initial supplies and resupplies for assigned studies, Designs and implements strategic plans to supply study drugs to complex global clinical trials using sound supply chain techniques
• Acts as IRT System Lead supports vendor selection activities, gathers, and provides input into user requirement specifications of Interactive Response Technology (IRT) management module(s)
• Reviews IRT strategy to ensure it supports the strategic supply plans and ensures that IRT is settings are adjusted to optimize the supply chain
• Leverages the inventory management capabilities of the IRT to appropriately manage studies

Requirements:

• Bachelor’s degree in science, engineering, or another relevant field
• Eight-plus years of relevant biopharmaceutical industry experience with four-plus years of clinical supplies, and clinical trial experience
• Experience with Interactive Response Technology (IRT)
• Experience with investigational drug product packaging and labeling and distribution processes
• Understanding of clinical study design, execution, and importance of investigational drug supply and management
• Experience with the clinical trial process from study start-up through study closure
• Experience managing diverse project activities with contract CMO facilities at different global locations
• Outstanding project management skills: proven ability to work independently, prioritize, and manage multiple tasks simultaneously
• Strong computer skills including MS Office (MS Project)
• Hands-on, roll-up-your-sleeves approach with a high sense of urgency and drive for results
• Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills
• Ability to think outside of the box and challenge the status quo
• Natural entrepreneurial spirit with unrelenting dedication to delivering results
• Desire to work in a fast-paced, innovative environment
• Natural collaborator who enjoys working on a cross-functional team