Vice President, Global Supply Chain

Rezolute•Redwood City, CA

4d•Onsite

About The Position

The Vice President, Global Supply Chain is a key member of Rezolute’s Technical Operations Leadership team, responsible for building, leading, and overseeing the company’s global clinical and commercial supply chain. The role covers product storage after shipment from manufacturing through labeling, packaging, finished drug product, depots, third-party logistics operations, and distribution to clinical sites, patients, and partners. The position owns the Sales and Operations Planning (S&OP) process, the finished drug product supply plan, and the ERP inventory management system supporting them. As a member of the Launch Team, the Vice President works closely with Commercial, Commercial Patient Services, Regulatory, and ex-US Commercial and Regulatory teams on launch readiness, market-entry supply plans, and country-specific labeling, artwork, and packaging configurations. The role designs the transition from a clinically oriented supply chain to an integrated global clinical and commercial model that can support direct and partnered markets while retaining the agility required of a late-stage rare disease company. It leads clinical supply and commercial supply planning, establishes distribution and trade-compliance capabilities, manages supply-chain risk and partner governance, and supports global submissions in coordination with Quality and Regulatory. The position reports to the Senior Vice President, Operations (and Head of Technical Operations) and works in close partnership with the Head of Quality and Vice President, Global Manufacturing. It is intended to be based at Rezolute’s Redwood City office. Domestic and international travel may be required, up to 50% for a remote employee.

Requirements

Bachelor of Science degree in a related field is required.
At least 15 years of pharmaceutical or biotech supply-chain experience.
At least 5–7 years in senior leadership, with demonstrated executive experience at the Vice President or Executive Director level.
Hands-on experience building a supply-chain function, including its systems, procedures, and team, in a late-stage-to-commercial biotech context.
Commercial launch experience, 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.
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 extensions, and expanded access programs.
Experience implementing serialization and global trade compliance for temperature-regulated biologics.
Ability to lead through influence, act with agility, lead problem solving, and drive toward robust solutions.
Strong communication skills demonstrated at all levels of an organization.
The position is based in Redwood City, California; domestic and international travel may be required, up to 50% for a remote employee.

Nice To Haves

An advanced degree or MBA.
APICS/ASCM certification.
Rare disease experience.
Rare disease commercial launch experience.
NetSuite experience.
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.
A sense of humor and humility.

Responsibilities

Design, develop, and implement the transition to an integrated global clinical and commercial supply chain.
Oversee clinical and commercial supply channels, including product storage, labeling and packaging, finished drug product, depots, 3PL operations, and distribution.
Lead the Clinical Supply team and manage supply-chain elements of the current Plan of Record, including supply for advanced Phase 3 programs and preparation for potential global launches.
Own the Commercial Supply Chain Integrated Plan and contribute to the Integrated Launch Plan for each indication.
Own and lead the S&OP process with Commercial Operations, Market Access, Patient Services, Clinical Operations, Finance, and Global Manufacturing to reach consensus on demand and supply plans, inventory targets, scenarios, cost of goods, and spending.
Own the finished drug product supply plan to global channels, aligned with the Manufacturing Plan.
Develop, implement, and maintain a GMP- and SOX-compliant ERP inventory management system for end-to-end inventory visibility, lot traceability, and financial control.
Work with Commercial and Regulatory to define final labels, artwork, packaging configurations, and the process for managing artwork and labeling for country-by-country market entry.
Lead supply-chain launch readiness, including launch inventory, channel readiness, 3PL and distributor onboarding, and integration with Commercial Patient Services.
Partner with ex-US Commercial and Regulatory teams on country-specific supply plans, packaging configurations, and distribution models for direct and partnered markets, including named-patient and early-access supply where applicable.
Establish a commercial distribution network, including 3PLs, specialty distribution, and specialty pharmacy channels, aligned with the Commercial channel strategy.
Establish logistics and global trade compliance capabilities for controlled, compliant international movement of temperature-regulated product using validated means.
Implement serialization and track-and-trace capabilities to support applicable global regulations, including DSCSA and EU FMD.
Identify and mitigate risks to product supply for clinical sites and global markets; assess risks, implement mitigation plans, and escalate as appropriate.
Establish governance with packaging, labeling, depot, 3PL, and distribution partners to clarify work, costs, risks, and deliverables.
Lead onboarding and transfers of labeling, packaging, depot, 3PL, and distribution service providers, including relationship, program, contract, and deliverable management.
Partner with the MSAT team within Quality on relevant work; the posting specifies that MSAT owns technical specification, characterization, qualification and validation, and Module 3 authorship.
Support global submissions relating to labeling, packaging, and distribution in coordination with Quality and Regulatory.
Build, lead, manage, and develop a high-performance, phase-appropriate team covering clinical supply, demand and supply planning, labeling and packaging, commercial distribution, 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 with the Head of Quality on GDP compliance, finished drug product disposition, temperature-excursion management, complaints, returns, recall readiness, and vendor qualification.
Partner with the Vice President, Global Manufacturing to ensure a seamless drug product handoff and alignment between finished drug product supply and manufacturing plans.
Manage supply-chain financial matters, including budgeting, forecasting, long-range planning, inventory levels and valuation with Finance, expiry and write-off management, and packaging and distribution cost of goods.
Develop and manage partner relationships and contracts in coordination with Legal, Finance, Quality, and functional heads, seeking cost-efficient arrangements that meet near- and long-term needs.
Establish supply-chain KPIs, including service level, On Time In Full, inventory health, and forecast accuracy, and report performance to the Technical Operations Leadership team and Launch Team.
Promote open, honest communication and collaboration as part of the Technical Operations Leadership team.
Travel domestically and internationally as required; remote employees may travel up to 50%.

Benefits

Competitive compensation.
Stock options.
Medical, dental, and vision insurance.
Disability, life, and long-term care insurance.
Holiday pay.
Tracking Free Vacation Program.
401(k) plan match.
Educational assistance benefit.
Fitness center reimbursement.
Annual performance bonus, subject to the applicable plan and company and individual performance.