Vice President - Global Supply Chain

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 FMD).

• Accountable for identification and mitigation of risks to the supply of product to clinical sites and global markets; routinely assesses risks within the span of control, creates and implements effective mitigation plans, escalating as appropriate.

• Applies a suitable governance structure with packaging, labeling, depot, 3PL and distribution partners to drive open, contemporaneous and clear understanding of conduct of work, costs, risks and deliverables.

• Enables transfers and onboarding of labeling, packaging, depot, 3PL and distribution service providers by establishing the relationship and leading program, contract and deliverable management. Partners with the MSAT team within Quality, which owns technical specification, characterization, qualification and validation, and Module 3 authorship.

• Supports global submissions with respect to labeling, packaging and distribution in concert with Quality and Regulatory teams.

• Works as part of a broader Technical Operations Leadership team, striving for open, honest communication and collaboration.

Areas of specific responsibility include:

• Build, lead, manage and develop a best-in-class, high-performance, phase-appropriate team, including clinical supply, demand and supply planning, labeling and packaging, commercial distribution and logistics, and trade compliance.

• Build phase-appropriate supply chain systems, procedures and work instructions for planning, inventory management, labeling and packaging, distribution and partner oversight.

• Work diligently with the Head of Quality to maintain seamless integration with all aspects of the Quality team, including GDP compliance, FDP disposition, temperature excursion management, complaints, returns and recall readiness, and vendor qualification.

• Partner with the Vice President, Global Manufacturing to ensure a seamless handoff of Drug Product into the global supply chain, and alignment between the FDP supply plan and the Manufacturing Plan.

• Ensure the management of all financial aspects of the supply chain, including budgeting, forecasting, long-range planning, inventory levels and valuation (with Finance), expiry and write-off management, and Cost of Goods for packaging and distribution.

• Lead development of relationships and contracts with packaging, labeling, depot, 3PL and distribution partners, negotiated to meet the near- and long-term needs of Rezolute in a cost-efficient manner, as agreed with Legal, Finance, Quality and functional heads.

• Establish supply chain KPIs (service level, On Time In Full, inventory health, forecast accuracy) and report performance to the Technical Operations Leadership team and Launch Team.

Qualifications/Requirements - We are looking for a candidate with:

• 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, demonstrated at all levels of the organization; sense of humor and humility are essential.
• Position is based in Redwood City, CA, and may require domestic and international travel (up to 50%) for remote employee.
Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that has:
• 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.
• Act with HONOR: Honesty, Open with Direct Communication, Nimbleness, Open-minded, Respect.