Clinical Supply Chain Manager

2 months ago

Houston, Texas, United States Neurogene Inc. Full time

About Neurogene Inc.

At Neurogene, we are dedicated to delivering transformative genetic therapies to individuals and families impacted by rare and severe neurological disorders. Our clinical-stage organization is advancing NGN-401 for Rett syndrome and NGN-101 for CLN5 Batten disease. Utilizing our proprietary EXACT transgene regulation technology, we are pioneering innovative strategies to overcome the challenges of traditional gene therapy in central nervous system conditions. Our fully operational GMP-capable manufacturing facility supports vector production from research through clinical grade, designed for commercial-grade output. Neurogene is publicly traded on the NASDAQ Global Market, and our mission is driven by a collaborative workforce committed to improving the lives of patients and their families.

Position Overview

The Clinical Supply Chain Manager will oversee the planning and delivery of products in development, ensuring effective clinical supply management, packaging, labeling, Randomization and Trial Supply Management (RTSM), distribution, logistics planning, and budget development and tracking for clinical supplies. This role is critical in managing and executing the clinical supply chain for ongoing and new clinical studies and programs.

Key Responsibilities

  • Possess expertise in clinical supply forecasting, sourcing, packaging, labeling, distribution, clinical trial operations, project management, pharmaceutical research and development, and inventory management.
  • Drive the coordination and execution of all clinical supply-related activities, including supply planning, cGMP secondary packaging, labeling, distribution, and logistics for global R&D clinical programs.
  • Understand clinical production processes and design strategies for patient kits to align with clinical study designs.
  • Support RTSM User Specifications and User Acceptance Testing (UAT) as necessary.
  • Implement global clinical supply chain sourcing strategies, collaborating with third-party providers for current and future programs.
  • Manage supplier relationships with clinical supply vendors, maintaining key performance metrics and overseeing budget and invoice tracking.
  • Evaluate vendor selection to support clinical studies based on capability and alignment with outsourcing strategies.
  • Address budget and invoicing considerations with vendors, ensuring alignment with study management details.
  • Collaborate with supply chain colleagues to ensure consistency across processes and implement improvements for sustainable results.
  • Understand the roles and responsibilities of all functions involved in cross-functional drug development teams.
  • Act as a liaison between clinical study leaders and external clinical supply vendors.
  • Ensure the quality of clinical supplies and packaging meets regulatory, GCP, and GMP standards, resolving any related issues as necessary.
  • Work with Regulatory Affairs, CMC, QA, Clinical Operations, and vendors to establish processes for providing clinical supplies for global studies.
  • Develop and manage procedures for the importation and exportation of clinical supplies globally, including planning for the return, storage, and destruction of supplies post-study.
  • Exhibit a proactive attitude while respectfully challenging partners regarding project timelines, finances, and scope.
  • Contribute to the review and revision of clinical documents, Standard Operating Procedures, guidelines, and departmental policies as needed.
  • Perform additional duties as assigned.

Qualifications

  • Bachelor's Degree or higher, or relevant experience in a clinical research environment.
  • A minimum of 8 years of experience in clinical supply chain and logistics management; development experience is a plus.
  • Experience with gene therapy products is highly desirable.
  • Demonstrated experience in multi-functional areas (Clinical, Regulatory, Quality, Product/Process Development) with a comprehensive understanding of pharmaceutical development in GCP and GMP.
  • Knowledge of medical device products, supply, and procurement is preferred.
  • Exceptional interpersonal, verbal, and written communication skills.
  • Ability to manage multiple priorities and tasks concurrently.
  • Strong focus on meeting or exceeding expectations in deliverables and performance outcomes.
  • Ability to track and measure performance against established metrics.
  • Self-motivated with a high degree of energy and initiative, capable of instilling urgency within the team.
  • A proactive individual who acts decisively while maintaining balance, with a passion for contributing to a growing organization.
  • Collaborative, creative, and willing to take calculated risks, motivated by the mission of developing transformative treatments for patients and their families.

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