Head of Global Product Supply
Company Description
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI)
Position Description
Overview
A key member of Rezolute ’s Technical Operations Leadership team, the Head of Global Product Supply has the mandate to provide the vision, leadership, strategy and management skills to build, lead and oversee the team’s transition from the development and supply of proprietary clinical stage programs to a fully externalized, globally enabled and integrated manufacture and supply team, supporting direct and partnered markets. In particular, the Head of Global Product Supply will have oversight over the company’s externalized manufacturing and supply chain platform, supporting the submission, approval, launch and supply of ersodetug, globally. The position reports to the Head of Operations, working daily in collaboration with the Head of Quality, Clinical Operations, Commercial Leadership Team, Regulatory and the RZLT Management Team, while acting as a pivotal source of information for the Board of Directors.
Principle Duties and Responsibilities Include:
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Charged with designing, developing and implementing the transition of the existing, clinically oriented functions toward a robust and reliable manufacturing and supply group, positioned to support global markets. In this, the organization must maintain its agile operational capability while installing the rigidity necessary to meet market demand through use of a fully externalized network of vendors. In this, the Head of Global Product Supply will partner closely with the Head of Quality to deliver a unified, robust manufacture and supply platform, suitable for scale of global supply.
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Accountable for the current Plan of Record, inclusive of late phase clinical supply supporting two Phase 3 pivotal (global) studies in rare disease.
Provides oversight, leadership and management as needed to meet program milestones, manufacturing of drug substance, drug product and finished drug product. In parallel provides executive leadership, management to guidance to addresses risks associated with global supply of Investigational Product to depots, subdepots and clinical sites through an existing Clinical Supply Team.
Works to continuously develop the manufacturing and supply chain operation and teams to ensure robustness and reliability of supply; Will rebuild the clinical supply chain as a priority through hiring or key resource, definition and deployment of process and procedure, and robust management and monitoring of daily execution.
Works closely with Quality, Clinical Operations, Regulatory and Finance to sustain a very dynamic clinical supply program, continuing to identify shortfalls or risks to supply; Leads an agile team to successful outcomes in support of near-term Corporate Goals/Strategy and Milestones.
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Accountable for all externalized manufacturing, shipping, distribution, labeling, packaging and storage, via a global network of qualified vendors; Responsible for the processes utilized by Rezolute to manage and oversee vendor readiness and execution to ensure Right First Time, On Time In Full supply to clinical and commercial supply chains.
Develops strategy, tactics and deliverables for establishment of global supply of ERSODETUG for multiple indications.
Accountable for identification and mitigation of risks to the supply of product to the clinical and/or global markets; Routinely assess and define risks associated with in the span of control, create and implement effective mitigation plans, escalating as appropriate.
Accountable for identification, implementation and maintenance of robust manufacturing, i