Vice President, Global Supply Chain

Position Overview

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.

Principal Duties and Responsibilities

• Design, develop and implement 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.
• Accountable for all clinical and commercial supply channels, including labeling and packaging, country-specific labeling and packaging, 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, and leads the Clinical Supply team.
• Owns and leads the S&OP process in partnership with Commercial Operations, Market Access, Patient Services, Clinical Operations, Finance and Global Manufacturing.
• 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.
• Works with Commercial and Regulatory to define final label, artwork and product packaging configuration, and establishes the artwork and labeling management process.
• Forward-facing member of the Launch Team; accountable for supply chain launch readiness, including launch inventory, channel readiness, 3PL and distributor onboarding.
• Partners with the ex-US Commercial and Regulatory teams to develop country-specific supply plans, packaging configurations and distribution models.
• Establishes a commercial distribution network, including selection and integration of 3PL(s), specialty distribution and specialty pharmacy channels.
• Establishes a Logistics and Global Trade Compliance capability enabling the controlled and compliant movement of temperature-regulated product across international borders.
• Implements a serialization and track-and-trace platform ensuring compliance with global regulations (e.g., DSCSA, EU FMD).
• Accountable for identification and mitigation of risks to the supply of product to clinical sites and global markets.
• Applies a suitable governance structure with packaging, labeling, depot, 3PL and distribution partners.
• Enables transfers and onboarding of labeling, packaging, depot, 3PL and distribution service providers.
• Supports global submissions with respect to labeling, packaging and distribution in concert with Quality and Regulatory teams.
• Build, lead, manage and develop a best-in-class, high-performance, phase-appropriate team.
• Build phase-appropriate supply chain systems, procedures and work instructions.
• Work diligently with the Head of Quality to maintain seamless integration with all aspects of the Quality team.
• Partner with the Vice President, Global Manufacturing to ensure a seamless handoff of Drug Product into the global supply chain.
• Ensure the management of all financial aspects of the supply chain, including budgeting, forecasting, long-range planning, inventory levels and valuation, expiry and write-off management, and Cost of Goods.
• Lead development of relationships and contracts with packaging, labeling, depot, 3PL and distribution partners.
• Establish supply chain KPIs (service level, On Time In Full, inventory health, forecast accuracy) and report performance.

Qualifications/Requirements

• B.S. in a related field is required; advanced degree or MBA preferred; APICS/ASCM certification a plus.
• 15+ years of pharmaceutical/biotech supply chain experience, including 5–7+ years in senior leadership with demonstrated executive experience at the Vice President or Executive Director level.
• Demonstrated hands-on experience building a supply chain function, its systems, procedures and team, in the context of a late phase to commercial biotech; Rare Disease experience highly preferred.
• Commercial launch experience required (rare disease preferred), with direct accountability for a launched product through commercial labeling and packaging, 3PL, specialty distribution and specialty pharmacy channels.
• Experience designing and leading an S&OP process from launch through commercial supply.
• Experience leading the design and implementation of GMP and SOX compliant ERP inventory management systems; NetSuite experience preferred.
• Experience defining label, artwork and packaging configurations and supply models for multi-country market entry.
• Experience managing global clinical supply for pivotal studies, open label extension and EAP.
• Experience implementing serialization and global trade compliance for temperature-regulated biologics.
• Comfort in leading through influence, acting with agility, leading problem solving and driving toward robust solutions; communication is a critical strength; sense of humor and humility are essential.

Preferred Experience, Special Skills and Knowledge

• Experience supporting ex-US launches through direct and partnered models in the EU and other regions.
• Experience working directly with Commercial Patient Services and hub providers on patient access.