Rezolute
Manager, Clinical Supply Chain
Redwood City
Sponsorship not specified$140k-$165kDetected 61 days ago
ComplianceForecastingBudgetingSupply ChainClinical TrialsGMPDemand Planning
About the role
- Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI).
- The individual will work amongst a team 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.
- Ability to work in a highly collaborative, virtual, entrepreneurial environment leveraging external collaborations to accomplish individual and team goals.
Responsibilities
- Partner cross-functionally to support a quality-focused, patient-first supply chain network
- Manage global IP, including distribution, inventory, forecasting, and supply planning; oversee returns, reconciliation, and destruction
- Interpret protocols and collaborate with study and supply chain teams to ensure the right-first-time delivery of IP globally
- Works collaboratively with Clinical Operations to specify, set up, test, validate, and operate an IRT. Act as an Unblinded Drug Manager within IRT
- Manage vendors supporting clinical labeling, packaging, storage, and distribution; monitor performance and escalate as needed
- Support clinical label development processes, including content, design, approval, and translations
- Develop and maintain clinical demand forecasting models for assigned clinical studies, including Expanded Access Programs
- Identify supply risks and support the implementation of mitigation plans to avoid supply disruptions
- Engage in supply chain process improvements to support regulatory compliance and agency inspection readiness
- Ensure clinical supply activities comply with cGMP, GDP, and relevant global/country-specific regulations; support eTMF filings
Compensation
- Rezolute (RZLT) currently anticipates the base salary for the Manager 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
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