At Neurogene, we focus on bringing life-changing genetic medicines to patients and families affected by rare, devastating neurological diseases. Our clinical-stage company is developing NGN-401 for the treatment of Rett syndrome and NGN-101 for the treatment of CLN5 Batten disease. We are using our proprietary EXACT transgene regulation technology and internal expertise to develop novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. Our wholly owned and fully operational GMP-capable manufacturing facility supports vector production from research through clinical grade and is designed for commercial-grade production. In addition, Neurogene is now trading on the NASDAQ Global Market. This transformative work is driven by our highly collaborative people and comes together to bring us closer to achieving our mission of turning devastating diseases into treatable conditions, to improve the lives of patients and their families. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.
Position Overview
Manage the supply planning and delivery of products in development by supporting clinical supply management, clinical supply packaging and labelling, Randomization and Trial Supply Management (RTSM), distribution, logistics planning and clinical supply budget development and tracking. Manage and execute the clinical supply chain for current and new clinical studies and programs.
The Manager, Clinical Supplies may also serve as the functional leader and subject matter expert for the internal Chemistry Manufacturing & Controls (CMC), Quality Assurance (QA), and Clinical Operations (CO) teams. The incumbent will work collaboratively with other senior/functional leaders in the achievement of departmental and corporate objectives and initiatives.
Accountabilities and Responsiblities
Experience with any or all of the following functions or processes are highly preferred: clinical supply forecasting/sourcing/pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, and inventory management.
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.
Knowledge of clinical production processes and design strategy for patient kits to support the clinical study design.
Support the RTSM User Specifications and UATs as appropriate.
Execute global clinical supply chain sourcing strategy utilizing 3rd party providers in coordination with CO for current and future programs.
Coordinate supplier relationships with clinical supply vendors which includes maintaining key performance metrics and budget/invoice tracking, reviews initial supply needs for start-up, ongoing resupply strategy, contract negotiation and amendments and closeout requirements.
Evaluates vendor selection to support clinical studies according to capability and fit with outsourcing strategy and selection of contractors is made in agreement with line management.
Addresses budgets and invoicing considerations with vendors along with study management details and capture any impacts.
Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results.
Understanding of the roles and responsibility of all functions represented on cross functional drug development teams.
Serve as a liaison between the clinical study leaders and external clinical supplies vendors.
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.
Work with Regulatory Affairs (RA), CMC, QA, CO and vendors, etc. to develop process for providing clinical supply for global clinical studies.
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.
Brings a "can-do" attitude while being able to respectfully challenge partners and be assertive when necessary around project timelines, finances, and scope.
May contribute to the review and revision of clinical documents (e.g., protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards), Standard Operating Procedures, guidelines, and departmental policies.
Other duties as assigned.
Requirements
Bachelor's Degree or higher or previous experience working directly in a clinical research setting.
Minimum 8 years of experience handling / leading clinical supply chain and logistics; 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.
Experience and/or knowledge of medical device products, supply and procurement preferred.
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, as illustrated by the ability to instill a sense of pace and urgency into the team.
Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.