Sr. Director, Commercial Supply Chain
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.
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
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.
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.
Promote preparedness for regulatory filings and commercialization by partnering with CMC, Regulatory, and Clinical Operations teams.
Oversee vendor technical assessments and supplier qualification processes.
Qualifications
15+ years of progressive supply chain leadership experience in pharmaceutical or biotech industry.
Direct responsibility for supply chain function and team that supported the launch drug required.
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.