Clinical Supply Chain Manager
3 weeks ago
At Neurogene Inc., we are committed to developing life-changing genetic medicines for patients and families affected by rare neurological diseases. Our clinical-stage company is dedicated to bringing innovative treatments to those in need.
Job SummaryWe are seeking a highly skilled Manager, Clinical Supplies to join our team. The successful candidate 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, and Quality Assurance, 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.
- Bachelor's Degree or higher in a relevant field, or previous experience working directly in a clinical research setting.
- 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.
- 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.
Neurogene Inc. is a clinical-stage company dedicated to developing innovative genetic medicines for patients and families affected by rare neurological diseases. Our team is passionate about bringing life-changing treatments to those in need, and we are committed to making a difference in the lives of our patients and their families.
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Houston, Texas, United States Neurogene Inc. Full timeAbout 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...
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