Senior Manager, Clinical Supply Chain

Rezolute - Redwood City, CA

Full-time - Senior

Redwood City, CA

Chemical Manufacturing

About the position

The Senior Manager, Clinical Supply Chain will be responsible for ensuring the continuous supply of Investigational Product to Rezolute's multiple clinical trials and Named Patient programs. This role involves close collaboration with Technical Operations colleagues from Supply Operations, FDP Manufacturing and Labeling, and Quality Assurance. The individual will act as a liaison with Clinical Operations to generate Clinical FDP distribution strategies and production plans. The position is situated within a team of CMC experts in a matrix organization, promoting a highly collaborative and agile environment to advance a pipeline of metabolic disease and orphan drug therapeutics. This role is 100% office-based at Rezolute's Redwood City office, reporting directly to the Senior Director, Global Supply Chain.

Responsibilities

• Lead the Clinical Supply Chain function at Rezolute, managing through depot to global clinical sites to ensure the continuous supply of quality product to patients.
• Develop Clinical FDP distribution strategies and manufacturing plans as a key member of clinical Study Management Teams.
• Partner with the Rezolute manufacturing organization to ensure timely delivery of Investigational Product to multiple clinical trials and Named Patient programs.
• Collaborate with Clinical Operations and Clinical Quality to enable IRT system design and setup, acting as the primary Unblinded Drug Manager within IRT to maintain inventory levels and initiate shipments.
• Work with Rezolute Quality to ensure a 'Quality First' mindset throughout the Supply Chain.
• Provide advanced operational support and technical communication to Global Health Authorities in support of CMC preparation, query resolution, and plant inspections.
• Author relevant sections of regulatory submissions and response materials; interface with regulators on all components of regulatory filings.
• Conduct vendor technical/capability assessments and support the Vendor (Supplier) Qualification Process.

Requirements

• Experience managing global clinical supply for multiple Phase 3 studies and named patient programs.
• Advanced degree in a related field with at least 5 - 7 years' experience in a highly regulated pharmaceutical Clinical Supply Chain role.
• Experience working on the design and implementation of IRT systems, with Suvoda IRT experience preferred.
• Experience leading the design and implementation of global clinical distribution networks, including final mile delivery, ensuring continuous supply of temperature regulated Investigational Product.
• Comprehensive knowledge of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices, and global regulations.
• Willingness to travel domestically and internationally as required (up to 5%).
• Ability to work in a highly collaborative, virtual, entrepreneurial environment leveraging external collaborations to accomplish individual and team goals.

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-mindedness, Respect.

Benefits

• 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