Job Description

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/Associate Director, 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% REMOTE, proximity to Rezolute’s Redwood City office is preferred.

Duties and Responsibilities:

• Work cross functionally with Clinical, Quality, Regulatory, Supply Chain, external vendors, and other subject matter experts to create and maintain a quality focused, patient-first supply chain network.
• Manage clinical supply demand and supply models for Rezolute’s clinical programs, including Expanded Access Programs
• Act as the supply chain lead on clinical study teams and supply chain teams to interpret protocols and ensure the right first time manufacturing and delivery of drug globally
• Interpret protocol to develop packaging/labeling designs, design global supply strategies, ensure depot inventory accuracy, and returns.
• Act as the primary Unblinded Drug Manager within IRT. Manage global study inventories manually and or through the IRT, adjust site supply and distribution plan accordingly.
• Manage clinical label development processes, including clinical label content, label design, approval, and translations, and associated vendors.
• Manage contract manufacturing sites responsible for clinical labeling, packaging, distribution, label design/ translation, and returns/ destruction. Schedule / manage packaging operations at vendors according to trial timelines.
• Support financial planning for clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline
• Partner with the Rezolute manufacturing organization to ensure timely delivery of Drug Product vials to adhere to finished goods production timelines.
• Proactively lead and drive supply chain process improvements to support Regulatory compliance and agency inspection readiness.

Qualifications/Requirements:

• Minimally, an undergraduate degree in a related field with at least 7 years of experience in a highly regulated pharmaceutical Clinical Supply Chain role
• Understanding of the clinical trial process, experience managing global clinical supply for blinded, Phase 3 studies and named patient programs
• Import/ Export logistics experience in a GxP environment
• Experience programming and managing supply chain functions within IRT, as well as leading the UAT process.
• Experience developing clinical distribution networks, including final mile delivery, enabling the continuous supply of temperature-controlled products
• Willingness to travel domestically and internationally as required (up to 10%)

Preferred Experience, Special Skills and Knowledge:

• Strong analytical skills and ability to effectively communicate complex information 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/Associate Director of Clinical Supply Chain role could range from $175,000 to $210,000 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.

Job Tags

Similar Jobs