Vice President, Global Supply Chain

Rezolute•Redwood City, CA

5d•$290,000 - $340,000

About The Position

Rezolute is a late-stage rare disease biopharmaceutical company developing therapies for severe metabolic and endocrine disorders. The Vice President, Global Supply Chain is a key member of the Technical Operations Leadership team and is responsible for building, leading and overseeing the company’s global clinical and commercial supply chain. The scope runs from storage of drug product after shipment from the manufacturing site through labeling, packaging, finished drug product, depots, third-party logistics operations and distribution to clinical sites, patients and partners. The role owns the Sales and Operations Planning (S&OP) process, the finished drug product supply plan to global channels, and the ERP inventory management system supporting them. As a forward-facing member of the Launch Team, the Vice President partners with Commercial, Commercial Patient Services, Regulatory, and ex-US Commercial and Regulatory teams on launch readiness, market entry, labeling, artwork and packaging configuration. The role reports to the Senior Vice President, Operations (and Head of Technical Operations) and works closely with the Head of Quality and Vice President, Global Manufacturing to deliver an integrated manufacturing and supply platform. The position 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. The role leads the development of a phase-appropriate supply chain organization, systems and procedures. It is accountable for clinical and commercial supply, supply risk mitigation, distribution and logistics, global trade compliance, serialization, financial management, partner governance and supply-chain performance reporting. The position also supports global submissions in coordination with Quality and Regulatory.

Requirements

Bachelor of Science degree in a related field.
15 or more years of pharmaceutical or biotechnology supply-chain experience.
Five to seven or more 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 systems, procedures and a team, in a late-stage to commercial biotechnology setting.
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 labeling, artwork and packaging configurations and supply models for multi-country market entry.
Experience managing global clinical supply for pivotal studies, open-label extensions and early 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 robust solutions.
Strong communication skills demonstrated at all organizational levels; a sense of humor and humility are essential.

Nice To Haves

Advanced degree or MBA.
APICS/ASCM certification.
Rare disease 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.

Responsibilities

Design, develop and implement the transition from a clinically oriented supply chain to an integrated global clinical and commercial supply chain that can support direct and partnered markets.
Oversee clinical and commercial supply channels, including drug product storage, labeling and packaging, finished drug product, depots, third-party logistics operations and distribution.
Manage clinical supply for the current Plan of Record, including investigational product supply for two advanced Phase 3 programs, pre-BLA preparation and potential global launches; lead the Clinical Supply team.
Own the Commercial Supply Chain Integrated Plan and contribute to the Integrated Launch Plan for each indication.
Own and lead S&OP with Commercial Operations, Market Access, Patient Services, Clinical Operations, Finance and Global Manufacturing, developing consensus demand and supply plans, inventory targets, scenarios, cost of goods and spending.
Own the finished drug product supply plan to global channels and align it with the manufacturing plan.
Develop and maintain a GMP- and SOX-compliant ERP inventory management system that supports end-to-end inventory visibility, lot traceability and financial control.
Work with Commercial and Regulatory to define labels, artwork and packaging configurations, and establish artwork and labeling management processes 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, including named-patient and early-access supply where applicable.
Establish a commercial distribution network, including 3PL, 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 products using validated means.
Implement serialization and track-and-trace capabilities to meet global regulations, including DSCSA and EU FMD.
Identify, assess and mitigate risks to supply for clinical sites and global markets, escalating risks as appropriate.
Establish governance with packaging, labeling, depot, 3PL and distribution partners to maintain clear understanding of work, costs, risks and deliverables.
Lead transfers and onboarding of supply-chain service providers, including relationship, program, contract and deliverable management; partner with the MSAT team on its technical responsibilities.
Support global submissions related to labeling, packaging and distribution in partnership with Quality and Regulatory.
Build, lead and develop a high-performance, phase-appropriate team spanning clinical supply, planning, labeling and packaging, commercial distribution, logistics and trade compliance.
Develop 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 excursions, complaints, returns, recall readiness and vendor qualification.
Partner with the Vice President, Global Manufacturing on drug product handoff and alignment between the finished drug product supply plan and manufacturing plan.
Manage supply-chain budgeting, forecasting, long-range planning, inventory levels and valuation, expiry and write-offs, and packaging and distribution cost of goods.
Develop and negotiate relationships and contracts with packaging, labeling, depot, 3PL and distribution partners in coordination with Legal, Finance, Quality and functional leaders.
Establish and report supply-chain KPIs, including service level, on-time in-full performance, inventory health and forecast accuracy.