Associate Director, Global Clinical Supply Chain

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazers in FcRn inhibitor technology, the Company is boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs.

Reporting To:
Sr. Director, Global Supply Chain

Location:

Flexible Work Environment

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Associate Director, Global Clinical Supply Chain will report to the Senior Director, Global Clincial Supply Chain. The Associate Director, Global Clinical Supply Chain possesses a good understanding of Clinical supply management, CMC, regulatory, project management terminology and demonstrates effective communication skills. The Associate Director, Global Clinical Supply Chain collects and assesses information from various sources including cross-functional teams, systems, tools, and communication with functional leads.

The Associate 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 rapid start-up of CDMOs, CROs to enable clinical study initiation at clinical sites and on-going support of the sites including returns and reconciliation. The Associate Director, Global supply chain, partners with the Clinical Operations group and CMC group to ensure continuous supply of Investigational Medicinal Product (IMP) for Immunovant trials.

Assist in the oversight of packaging and labeling vendors, distribution and set up and administering Interactive Response Technology (IRT) to supply study drug to global clinical trials using sound supply chain techniques.

• 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).
• Provides recommendations on packaging design, distribution and blinding strategy. Plans and manages execution of initial supplies and resupplies for assigned studies. Designs and implements plans to supply study drug to complex global clinical trials using sound supply chain techniques.
• Develops and executes inventory management plans for clinical sites and depots to ensure treatment availability for every patient visit.
• 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 close out activities including returned good reconciliation, inventory destruction processing, and file archiving.
• Manage the inventory and shipment logistics of all Immunovant 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, resolution to issues, and respond to questions related to CMC projects.
• 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.
• Perform all necessary tasks to ensure clinical supply chain for assigned trials operates effectively.

• Bachelor's degree in science, engineering, or another relevant field; advanced degree preferred.
• Five-plus years of relevant pharmaceutical/biotech industry experience.
• Experience with global pharmaceutical/biotech development and manufacturing operations for development-stage biologics, including upstream/downstream process development, formulation development (pre-filled syringe), analytical development, and device development.
• Experience managing diverse project activities with contract CMO facilities at different global locations;
  Experience with clinical supply management.
• Outstanding project management skills; proven ability to work…