Clinical Supply Chain Manager

1 week ago


Houston, Texas, United States Neurogene Inc. Full time
About the Role

We are seeking a highly skilled and experienced Clinical Supply Chain Manager to join our team at Neurogene Inc. As a key member of our organization, you will be responsible for managing the supply planning and delivery of products in development, supporting clinical supply management, clinical supply packaging and labeling, Randomization and Trial Supply Management (RTSM), distribution, logistics planning, and clinical supply budget development and tracking.

Key Responsibilities
  • Manage and execute the clinical supply chain for current and new clinical studies and programs.
  • Support and drive the coordination and execution of all clinical supply related activities, including supply planning/forecasting, cGMP secondary packaging/labelling, distribution, and logistics for R&D global clinical programs.
  • Develop and manage the procedures for the importation and exportation of clinical supplies globally and plan/execute the return, storage, and destruction of clinical supplies following the completion/termination of clinical studies.
  • Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results.
  • Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, Quality Assurance, and Chemistry Manufacturing & Controls, to ensure compliance with regulatory requirements and company policies.
  • Develop and manage budgets and invoicing considerations with vendors, as well as study management details and capture any impacts.
  • Ensure that the quality of clinical supplies and packaging is appropriate and meets regulatory, GCP, and GMP requirements.
  • Resolves issues related to clinical supplies as needed.
Requirements
  • Bachelor's Degree or higher in a relevant field, such as Supply Chain Management, Logistics, or a related field.
  • Minimum 8 years of experience handling/leading clinical supply chain and logistics, with some development experience preferred.
  • Experience working with gene therapy products is highly desired.
  • Experience in multi-functional areas (Clinical, Regulatory, Quality, Product/Process Development) demonstrating a broad understanding of pharmaceutical development, both in GCP and GMP.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to manage multiple conflicting priorities and varied concurrent tasks.
  • Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance, and results.
  • Ability to track and measure performance against defined metrics.
  • Self-starter with high degree of energy, independence, initiative, and self-motivation.


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