Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders
Position Summary
The Sr Director, Commercial Supply Chain will lead supply chain strategy and operations as Rezolute transitions from late-stage clinical development to commercial launch. This individual will establish scalable, compliant, and efficient supply capabilities to ensure uninterrupted supply of investigational and commercial products across global markets. The role requires a strategic, hands-on leader who can design the future-state operating model, build critical systems and partnerships, and lead a growing team through commercialization while supporting ongoing clinical supply operations.
Key Responsibilities
Strategic Leadership
- Develop and execute the supply chain strategy supporting launch and commercial operations both domestically and abroad.
- Define stage-appropriate operating models, governance, and organizational structure required to support commercial supply.
- Partner with External Manufacturing, Quality, Regulatory, and Finance to ensure seamless integration of supply, inventory, logistics, and planning activities.
- Serve as Supply Chain lead for commercialization readiness and launch planning initiatives.
Clinical Supply
- Serve as the senior functional leader and subject matter expert for Supply Chain Operations, including strategic and operational leadership. Support, guide, and integrate systems and capabilities that provide uninterrupted supply for ongoing and new clinical studies.
- Collaborate closely with the clinical supply leader to ensure comprehensive supply planning, risk management, and compliance with global GxP standards.
- Ensure alignment between clinical and commercial supply strategies to facilitate smooth transition through development and launch.
- Support clinical supply performance reviews, resource planning, and vendor management.
Supply & Inventory Planning
- Development a robust integrated supply and inventory planning system to ensure manufacturing readiness, continuity, and optimized global inventory levels.
- Establish and oversee Sales & Operations Planning (S&OP) processes to align supply, demand, and financial plans.
- Establish and maintain GMP and SOX-compliant inventory systems supporting both manufacturing and distribution needs.
- Lead scenario and risk-based planning to guide production and supply decisions.
- Optimize safety stock levels and manage excess and obsolete inventory to minimize working capital impact.
- Drive launch readiness through coordinated supply chain planning and execution.
Logistics & Trade Compliance
- Establish central Global Trade Compliance (GTC) framework including unified GTC policy, SOPs/WIs, and recordkeeping system(s) to support retention and audit requirements.
- Ensure compliant and efficient cross-border movement of materials through oversight of import/export operations, customs documentation, and duty optimization strategies.
- Collaborate across departments (e.g., External Manufacturing, Tech Ops) to coordinate decentralized logistics execution.
- Oversee Harmonized Tariff Schedule (HTS)classification and trade compliance audits and conduct periodic stakeholder training.
- Provide input and support for Shipping System Qualification (SSQ) activities to ensure the compliant and efficient movement of materials within the global logistics network
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3PL Distribution & Channel Supply
- Partner with Market Access to translate channel strategies into coordinated commercial distribution plans and oversee the execution of 3PL operations.
- Manage relationships with commercial 3PL providers, ensuring excellent performance and adherence to SLAs.
- Maintain oversight for global product serialization strategy, systems, operations, and regulatory compliance.
- Oversee warehousing, distribution, and product movement to ensure uninterrupted patient supply.
- Partner with Quality to establish procedures for product release, distribution, and returns.
- Establish distribution metrics and governance frameworks for 3PL service performance, costs, and compliance.
Cross-Functional Collaboration
- Build, lead, and develop a high-performing commercial supply chain organization suited for a commercial-stage biotech. Develop a talent pipeline and external partnerships to support long-term growth and scalability.
- Collaborate with Quality to promote a “Quality First” mindset, ensuring compliance with GCP, GMP, GDP, and relevant regulatory requirements across clinical and commercial supply chains.
- Partner with CMC, Regulatory, and Clinical Operations teams to ensure preparedness for regulatory filings and commercialization.
- Oversee vendor technical assessments and supplier qualification processes.
Qualifications
- 15+ years of progressive supply chain leadership experience in pharmaceutical or biotech industry.
- Demonstrated ability to provide strategic leadership and influence across functions in a fast-growing, high-pressure environment.
- Experience designing and managing US , EU and ROW supply chains for biologics and small molecules.
- Deep understanding of GxPs, cold chain logistics, and outsourced manufacturing models.
- Proven success in S&OP, supply and inventory planning, and risk management.
- In-depth understanding of global trade compliance and import/export regulations.
- Proven ability to build, lead, and develop cross-functional teams.
- Bachelor’s degree in supply chain management, engineering, life sciences, or related discipline required; MBA or advanced degree preferred.
- Demonstrated success leading clinical-to-commercial transition, including launch readiness and supply network establishment.
Preferred Attributes
- Strong cross-functional collaboration and partnership skills, with the ability to align and execute across diverse technical, operational, and commercial teams.
- Prior experience with rare disease or CGT supply chains.
- Global product launch and post-approval lifecycle management experience.
- ERP systems expertise and familiarity with advanced planning tools.
- Demonstrated agility and resourcefulness in fast-paced, scaling environments typical of high-growth biotech organizations.
Rezolute (RZLT) currently anticipates the base salary for the Sr. Director Commercial Supply Chain role could range from $225,000 to $280,000 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.