Manager, Clinical Supply Chain

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).

Position Description

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 Rezolute’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 other’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.

Duties and 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

Qualifications/Requirements:

• Bachelor’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%)

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Preferred Experience, Special Skills and Knowledge:

    - 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

Rezolute (RZLT) currently anticipates the base salary for the Manager Clinical Supply Chain role could range from $140,000 to $165,000 and will depend in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical / Dental / Vision)
• Disability, Life & Long-Term Care Insurance
• Holiday Pay
• Tracking Free Vacation Program
• 401(k) Plan Match
• Educational Assistance Benefit
• Fitness Center Reimbursement

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.