Vice President, Global Supply Chain

Rezolute; United States; Remote; USD 260,000 - 380,000; Full time

Job summary

Rezolute is seeking a Senior leader to oversee the global clinical and commercial supply chain, from drug product storage to regional and country depots, 3PL operations, and distribution to clinical sites and partners.

The VP will own the S&OP process, develop a GMP/SOX compliant ERP system, and collaborate with Regulatory, Commercial, and Manufacturing teams to support country-by-country market entry and launches.

Qualifications

• Experience leading global clinical and commercial supply chains for biopharma products.
• Proven ability to design supply chain processes across ERP, 3PL, depots and distribution.
• Strong cross-functional leadership and strategic planning capabilities.

Responsibilities

• Design and implement the transition to an integrated global clinical and commercial supply chain.
• Oversee storage, labeling, packaging, FDP and distribution to depots and sites.
• Lead the Clinical and Commercial Supply Chain Integrated Plans for launches.
• Own S&OP process with cross-functional partners to align demand and supply.
• Develop GMP and SOX compliant ERP inventory system with end-to-end visibility.
• Define final label and artwork configurations for country entry and supply.
• Prepare for launches with inventory, channel readiness, and onboarding.

Job description

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity. Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI).

A key member of Rezolute’s Technical Operations Leadership team, the Vice President, Global Supply Chain has the mandate to provide the vision, leadership, strategy and management skills to build, lead and oversee Rezolute’s global clinical and commercial supply chain, from storage of Drug Product once shipped from the manufacturing site through labeling, packaging, Finished Drug Product (FDP), regional and country depots, 3PL operations and distribution channels to clinical sites, global patients and partners. The role owns the S&OP process and the FDP supply plan to global channels, and the ERP inventory management system that supports them.

This role is forward facing as a member of the Launch Team and works closely with Commercial, Commercial Patient Services, Regulatory and the ex-US Commercial and Regulatory teams to define the final label, artwork and product packaging configuration supporting country-by-country market entry and supply. The position reports to the Senior Vice President, Operations (and Head of Technical Operations), and works daily in partnership with the Head of Quality and the Vice President, Global Manufacturing to deliver one seamless manufacture and supply platform. This role is intended to be based at Rezolute’s Redwood City office.

Principal Duties and Responsibilities Include:

• Charged with designing, developing and implementing the transition of Rezolute’s clinically oriented supply chain toward an integrated global clinical and commercial supply chain, positioned to support direct and partnered markets, while maintaining the agility required of a late-stage rare disease company.
• Accountable for all clinical and commercial supply channels, starting with storage of Drug Product once shipped from the manufacturing site, including labeling and packaging, country-specific labeling and packaging as required, Finished Drug Product, regional and country depots, 3PL operations and distribution channels.
• Accountable for the supply chain elements of the current Plan of Record, inclusive of global supply of Investigational Product to depots, sub-depots and clinical sites supporting two advanced P3 programs, preparing for preBLA enabling and preparation for potential launches globally, and leads the Clinical Supply team; owns the Commercial Supply Chain Integrated Plan, feeding the Integrated Launch Plan for each indication.
• Owns and leads the S&OP process in partnership with Commercial Operations, Market Access, Patient Services, Clinical Operations, Finance and Global Manufacturing, arriving at consensus demand and supply plans, inventory targets, scenarios, Cost of Goods and spend. Owns the FDP supply plan to global channels, from which the Vice President, Global Manufacturing derives the Manufacturing Plan.
• Develops, implements and maintains a GMP and SOX compliant ERP inventory management system, enabling end-to-end inventory visibility, lot traceability and financial control across clinical and commercial supply.
• Works with Commercial and Regulatory to define final label, artwork and product packaging configuration, and establishes the artwork and labeling management process supporting country-by-country market entry and supply.
• Forward-facing member of the Launch Team; accountable for supply chain launch readiness, including launch inventory, channel readiness, 3PL and distributor onboarding, and integration with Commercial Patient Services to enable rapid patient access.
• Partners with the ex-US Commercial and Regulatory teams to develop country-specific supply plans, packaging configurations and distribution models for direct and partnered markets, including named-patient and early-access supply where applicable.
• Establishes a commercial distribution network, including selection and integration of 3PL(s), specialty distribution and specialty pharmacy channels, aligned with the Commercial channel strategy.
• Establishes a Logistics and Global Trade Compliance capability enabling the controlled and compliant movement of temperature-regulated product across international borders through validated means.
• Implements a serialization and track-and-trace platform ensuring compliance with global regulations (e.g., DSCSA, EU