[Hiring] Associate Director, Global Clinical Supply Chain @IMVT Corporation

Role Description

The Associate Director, Global Clinical Supply Chain will report to the Senior Director, Global Clinical Supply Chain. The Associate Director possesses a good understanding of clinical supply management, CMC, regulatory, project management terminology and demonstrates effective communication skills. This role is responsible for the successful execution of supply chain management for clinical trials.

• Provides triage support to rapid start-up of CDMOs, CROs to enable clinical study initiation at clinical sites.
• Ongoing support of the sites including returns and reconciliation.
• Partners with the Clinical Operations group and CMC group to ensure continuous supply of Investigational Medicinal Product (IMP) for Immunovant trials.
• Assists in the oversight of packaging and labeling vendors, distribution, and administering Interactive Response Technology (IRT).

Key Responsibilities

• Managing and executing overall Project Delivery through coordination of CMC efforts assigned to the entire project team.
• 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.
• Manages 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.
• Reviews IRT strategy to ensure it supports the strategic supply plans.
• Leverages the inventory management capabilities of the IRT to appropriately manage studies.
• Performs all necessary tasks to ensure clinical supply chain for assigned trials operates effectively.

Qualifications

• 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.
• 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 and SmartSheets.
• Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results.
• Demonstrated communication, problem-solving, leadership, and 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.

Requirements

• Domestic or international travel are required (10-20%).

Benefits

• Salary range: $170,000 — $200,000 USD.
• Compensation based on market location and job-related knowledge, skills, and experience.
• Equity and other forms of compensation may be provided as part of a total compensation package.
• Full range of medical, dental, vision, 401k, and other benefits.
• Unlimited paid time off and parental leave.