Head of Global Product Supply

This is a fully remote position, open to applicants in California.

📋 Description

• Responsible for the design, development, and implementation of the transition from existing clinically oriented functions to a strong and dependable manufacturing and supply group, aimed at supporting global markets.

• Accountable for the current Plan of Record, which includes late-phase clinical supply for two pivotal Phase 3 global studies in rare diseases.

• Provides necessary oversight, leadership, and management to achieve program milestones and ensure the manufacturing of drug substance, drug product, and finished drug product.

• Continuously enhances the manufacturing and supply chain operations and teams to guarantee a robust and reliable supply; prioritizes rebuilding the clinical supply chain through strategic hiring, defining and deploying processes and procedures, and effectively managing daily execution.

• Collaborates closely with Quality, Clinical Operations, Regulatory, and Finance to maintain a dynamic clinical supply program, consistently identifying any supply shortfalls or risks; Leads an agile team towards successful outcomes in alignment with immediate Corporate Goals, Strategy, and Milestones.

• Responsible for all external manufacturing, shipping, distribution, labeling, packaging, and storage through a global network of qualified vendors; Oversees processes used by Rezolute to manage vendor readiness and execution to ensure Right First Time, On Time In Full supply to both clinical and commercial supply chains.

• Develops strategies, tactics, and deliverables for the establishment of global supply of ERSODETUG for various indications.

• Responsible for identifying and mitigating risks associated with the supply of product to clinical and/or global markets; Regularly assesses and defines risks within the scope of control, creating and implementing effective mitigation plans and escalating as necessary.

• Accountable for the identification, implementation, and maintenance of robust manufacturing, inventory management, and supply systems.

• Leads a collaborative team (including Quality, MSAT, and Technical Operations Leadership) to resolve deviations and investigations, ensuring reliable on-time supply.

• Partners with key functions (Commercial Ops, Market Access, Patient Services, Finance) to establish and maintain an S&OP process, developing supply and demand models, cost of goods sold (COGs), and expenditure to support clinical and commercial supply.

• Works cross-functionally to identify product lifecycle needs, facilitating feasibility, development, and implementation that aligns with product and corporate strategy.

⛳️ Requirements

• A Bachelor’s degree is required.

• Experience in commercial launch is required.

• Experience with biologics is required.

• 20+ years in progressive leadership roles in Manufacturing and Supply Chain within Life Sciences Start-up or Biotech organizations; Experience in Rare Disease is preferred.

• Proven track record of establishing a global commercial product supply chain and successful interactions with regulatory agencies, demonstrated by timely global submissions, approvals, and clinical and commercial supply of pharmaceutical compounds, specifically biologics drugs.

• Candidates should be comfortable leading through influence, demonstrating agility, solving problems, and driving towards effective solutions; Strong communication skills are essential, along with a sense of humor and humility.

• The position may require morning, evening, and/or weekend commitments due to the RZLT team being spread across the US, with vendors located offshore.

• The position may necessitate domestic and international travel (up to 50%).

🏝️ Benefits

• Health Insurance (Medical / Dental / Vision)