Vice President, Global Supply Chain
RezoluteRezolute 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). Position Description: O verview 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 readi…