Manager, Clinical Supply Chain

Rezolute•Redwood City, CA

9d•$140,000 - $165,000•Onsite

About The Position

Rezolute is a biopharmaceutical company seeking an experienced individual who can help lead its external late-stage to commercial manufacturing operations. 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). The Manager, Clinical Supply Chain is responsible for the execution and management of end-to-end clinical supply activities to ensure the uninterrupted supply of Investigational Product (IP) to Rezoluteâ€™s clinical trials and Named Patient programs. This role partners cross-functionally with Technical Operations, Clinical Operations, Quality, and Subject Matter Experts (SME) to support global supply, production, and distribution strategies and represents the Clinical Supply Chain team on study teams to enable successful trial execution. The individual will work amongst a team in a matrix organization, capitalizing on each otherâ€™s expertise in a highly collaborative and agile environment to advance a pipeline of metabolic disease and orphan drug therapeutics. Ability to work in a highly collaborative, virtual, entrepreneurial environment leveraging external collaborations to accomplish individual and team goals. Reporting to the Associate Director, Global Supply Chain, this role is Redwood City based.

Requirements

Bachelorâ€™s degree required, with at least 5 years of experience in a highly regulated pharmaceutical clinical supply chain role
Experience executing global clinical distribution activities, including last-mile delivery of temperature-controlled IP
Experience supporting blinded, Phase 1-3 studies and Expanded Access Programs
Strong knowledge of current Good Manufacturing Practices (cGMP) and global regulatory requirements governing clinical supply
Import/export logistics experience in a GxP environment
Hands-on experience configuring and managing supply chain functions within IRT, as well as participating in UAT process
Experience working with CMO and third-party vendors
Must be willing to travel domestically and internationally as required (up to 5%)

Nice To Haves

Strong leadership skills and ability to effectively communicate up, down and across the organization
Ability to effectively prioritize and deliver high-quality results on tight timelines
Excellent written, verbal communication and presentation skills
Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues
Act with HONOR: Honesty, Open with Direct Communication, Nimbleness, Open-minded, Respect

Responsibilities

Partner cross-functionally to support a quality-focused, patient-first supply chain network
Execute clinical supply activities across multiple studies, aligning with trial timelines and company priorities
Manage global IP, including distribution, inventory, forecasting, and supply planning; oversee returns, reconciliation, and destruction
Interpret protocols and collaborate with study and supply chain teams to ensure the right-first-time delivery of IP globally
Coordinate import licenses and other critical steps to ensure on-time delivery of IP
Works collaboratively with Clinical Operations to specify, set up, test, validate, and operate an IRT. Act as an Unblinded Drug Manager within IRT
Manage vendors supporting clinical labeling, packaging, storage, and distribution; monitor performance and escalate as needed
Support clinical label development processes, including content, design, approval, and translations
Develop and maintain clinical demand forecasting models for assigned clinical studies, including Expanded Access Programs
Identify supply risks and support the implementation of mitigation plans to avoid supply disruptions
Engage in supply chain process improvements to support regulatory compliance and agency inspection readiness
Ensure clinical supply activities comply with cGMP, GDP, and relevant global/country-specific regulations; support eTMF filings
Support financial planning and cost management for clinical supplies, including budgeting, forecasting, and cost tracking