Senior Manager, Clinical Supply Chain

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.Responsibilities Include:

Leading the Clinical Supply Chain function at Rezolute, managing 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.Candidate ProfileQualifications/Requirements –

We are looking for a candidate with:

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

– We are looking for a candidate that has:

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.Rezolute (RZLT) currently anticipates the base salary for the

Senior Manager, Clinical Supply Chain

role could range from $ 150,000

to $ 175,000

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.Qualifying employees are eligible to participate in benefit programs such as:Health Insurance (Medical / Dental / Vision)Holiday PayTracking Free Vacation ProgramEducational Assistance BenefitFitness Center ReimbursementWe 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.

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