Location: Redwood City, CA Onsite

Company Description

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 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. Working with Technical Operations colleagues from Supply Operations, FDP Manufacturing and Labeling and Quality Assurance, the individual will act as the liaison with Clinical Operations to generate Clinical FDP distribution strategies and production plans.

The individual will work amongst a team of CMC experts 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.

Reporting to the Senior Director, Global Supply Chain, this role is 100% office based at Rezolute’s Redwood City office.

Duties and Responsibilities:

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

Qualifications/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. Suvoda IRT experience preferred
• Experience leading the design and implementation of global clinical distribution networks, including final mile delivery, enabling the continuous supply of temperature regulated Investigational Product
• Comprehensive knowledge of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices and global regulations
• Must be willing 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

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

To Apply

Interested and qualified candidates should send a resume to recruiting@rezolutebio.com to the attention of Human Resources.

Rezolute (RZLT) currently anticipates the base salary for the Senior Manager of 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. Rezolute offers competitive compensation, stock options and a rich benefits package.

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.