Associate Director, Global Clinical Supply Chain

IMVT Corporation; United States; Remote; USD 170,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision

401k

Unlimited paid time off

Parental leave

Equity may be provided

Job summary

Immunovant, Inc. is seeking an Associate Director, Global Clinical Supply Chain to lead end-to-end supply management for clinical trials.

You will coordinate with CMC, regulatory, and external partners to ensure uninterrupted IMP supply, schedule manufacturing, packaging, labeling, and distribution globally. The role requires 5+ years in pharma/biotech supply chain, strong project management, and hands-on experience with CDMOs/CROs, IRT systems, and global logistics.

Qualifications

• Bachelor's degree in science, engineering, or another relevant field; advanced degree preferred.
• Five-plus years of pharmaceutical/biotech experience.
• Experience with global pharma development and manufacturing operations for development-stage biologics.

Responsibilities

• Managing and delivering overall project execution across CMC, Supply Chain, Regulatory, and Clinical Development.
• Recommend packaging design, distribution, and blinding strategies; plan initial supplies and resupplies.
• Develop inventory management plans for clinical sites and depots to ensure treatment availability.
• Interpret clinical protocols and create clinical forecasts.
• Oversee study close-out activities including returns reconciliation and destruction processing.
• Manage inventory and shipment logistics of Immunovant products and samples; ensure temperature control.

Skills

Project management

Cross-functional collaboration

Communication

Problem solving

Leadership

Strategic thinking

Education

Bachelor's degree in science or engineering

Advanced degree preferred

Tools

MS Office

Smartsheets

Job description

Associate Director, Global Clinical Supply Chain

Remote

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.

Associate Director, Global Clinical Supply Chain

Reporting To: Sr. Director, Global Supply Chain

Organizational Overview:

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 Role:

The Associate Director, Global Clinical Supply Chain will report to the Senior Director, Global Clincical 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.

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).


• 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 CMO 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.

Requirements:

• 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 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.


• Immunovant’s headquarters is located in North Carolina.


• Dynamic, interactive, fast-paced, and entrepreneurial environment.


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

Salary range for posting

$170,000 - $200,000 USD

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

As set forth in IMVT Corporation’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

Everyone is welcome to apply and we are committed to creating an inclusive environment.