2 days ago
πΊπΈ United States β Remote
π Massachusetts β Remote
β° Full Time
π Senior
π Supply Chain
β’ The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. β’ The Role: Reporting to the Director, Clinical Supply Chain, the Associate Director, Clinical Supply Chain will manage all aspects of the clinical drug supply chain, including forecasting, label creation/design, packing/labeling operations, clinical distribution management, and maintenance of clinical drug supply strategy. β’ Responsibilities: Represent Clinical Supply Chain on the Clinical Study teams and other clinical related cross-functional meetings to ensure Clinical Trial Material supply milestones are met across all programs.
β’ S./M.S. in a scientific field-or equivalent experience. Additional Project Management Training (PMP) would be beneficial. β’ Ten (10)+ years of experience in managing multiple Phase 1-4 and IIS studies, including critical Phase 3 global clinical supply chains in the Pharmaceutical and/or Biotech industry, either as a sponsor, vendor or CRO. β’ Experience managing vendors with strong understanding of regulatory requirements and guidelines governing labeling, packaging and distribution of clinical trial materials US/EU/ROW/Japan and Global country requirements (FDA/EMA/ICH). β’ Knowledge of proper GMP/GXP trial documentation and familiarity with documents required to be stored in the Trial Master File (TMF) regarding Clinical Supply Chain, IRT documents and drug supply source documents. β’ Temperature product management, experience with forecasting tools, deep understanding of GMP/GXP requirements and development/implementation of sponsor internal processes & SOPβs for greater compliance and efficiencies. β’ Ability to creatively solve Clinical Supply Chain issues. β’ Big picture understanding of the complete Drug Supply Chain: Drug Substance/Drug Product/Regulatory Submissions and steps required for compliant Drug Release approvals and Global Importation logistics process. β’ Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, etc.), experience with automated applications (Excel, Word, PowerPoint, Project, Smartsheet etc.), experience with automated inventory systems, forecasting software and ERP Inventory management is a plus.
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