Clinical Supply Chain Manager

2 weeks ago

Houston, Texas, United States Neurogene Inc. Full time

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 associated with traditional gene therapy for central nervous system conditions. Our fully operational GMP-capable manufacturing facility supports vector production from research to clinical-grade and is poised for commercial-grade output. Neurogene is also listed on the NASDAQ Global Market. This groundbreaking work is fueled by our collaborative workforce, united in our mission to convert debilitating diseases into manageable conditions, enhancing the lives of patients and their families. As a member of Neurogene, you will contribute to fostering a culture that values patient and caregiver perspectives while promoting innovation, creative problem-solving, and a profound sense of purpose.

Position Overview

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

The incumbent may also act as the functional leader and subject matter expert for the internal Chemistry Manufacturing & Controls (CMC), Quality Assurance (QA), and Clinical Operations (CO) teams. Collaboration with other senior leaders is essential to achieve departmental and corporate goals.

Key Responsibilities

  • Demonstrated experience in clinical supply forecasting, sourcing, packaging, labeling, distribution, clinical trial operations, project management, pharmaceutical/bio research and development, and inventory management is highly desirable.
  • Facilitate and lead 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.
  • Possess knowledge of clinical production processes and design strategies for patient kits to align with clinical study designs.
  • Support the RTSM User Specifications and User Acceptance Testing (UAT) as necessary.
  • Implement global clinical supply chain sourcing strategies in collaboration with third-party providers for current and future programs.
  • Manage supplier relationships with clinical supply vendors, including performance metrics maintenance, budget tracking, initial supply needs assessment, ongoing resupply strategies, contract negotiations, and closeout requirements.
  • Evaluate vendor selection to support clinical studies based on capability and alignment with outsourcing strategies, with contractor selection made in agreement with line management.
  • Address budget and invoicing considerations with vendors, ensuring alignment with study management details.
  • Collaborate closely with supply chain colleagues to ensure process consistency and implement improvements for sustainable results.
  • Understand the roles and responsibilities of all functions represented on 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, Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) standards, resolving any related issues as necessary.
  • Work with Regulatory Affairs (RA), CMC, QA, CO, and vendors to establish processes for providing clinical supplies for global studies.
  • Develop and manage procedures for the global importation and exportation of clinical supplies, including planning and executing the return, storage, and destruction of supplies post-study.
  • Exhibit a proactive attitude while respectfully challenging partners and asserting project timelines, finances, and scope when necessary.
  • Contribute to the review and revision of clinical documents, Standard Operating Procedures, guidelines, and departmental policies as needed.
  • Perform other duties as assigned.

Qualifications

  • Bachelor's Degree or higher, or equivalent experience in a clinical research environment.
  • A minimum of 8 years of experience in managing clinical supply chains and logistics, with some development experience preferred.
  • Experience with gene therapy products is highly valued.
  • Broad understanding of pharmaceutical development across multiple functions (Clinical, Regulatory, Quality, Product/Process Development) in both GCP and GMP contexts.
  • Familiarity with medical device products, supply, and procurement is preferred.
  • Exceptional interpersonal, verbal, and written communication skills.
  • Ability to manage multiple competing priorities and varied tasks concurrently.
  • Strong focus on meeting or exceeding expectations in deliverables, performance, and results.
  • Ability to track and measure performance against established metrics.
  • Self-motivated with a high degree of energy, independence, and initiative, instilling a sense of urgency within the team.
  • A decisive individual who is passionate about contributing to a growing company.
  • Collaborative, creative, and willing to take calculated risks, motivated by the development of transformative treatments for patients and their families.

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