Clinical Enterprise Logistics Lead

246036BR
Clinical Enterprise Logistics Lead
The Clinical Enterprise Logistics Lead is responsible for leading cell chain logistics for Cell and Gene Therapy clinical trials and commercial sites. CELL may also support other aspects of cell logistics and other clinical trial activities under the leadership of the Lead Clinical Trial Head (LCTH).
• Drive procedures, operations and improvements of clinical trial supply chain process to support cell therapy clinical trials • Point of contact for questions and problem resolution between manufacturing and Clinical sites (e.g. scheduling subjects in relation to apheresis, labeling, and on-boarding of sites) • Point of contact for questions and problem resolution between manufacturing and Novartis clinical teams (e.g. slots for manufacturing, batch records, etc) • Implement, manage, and oversee the preparation of training materials and presentations relating to supply chain and manufacturing for clinical sites • Author supply logistic manuals, protocols and related documents • Train clinical trial and manufacturing teams, CPOs, CRAs and infusion sites on cell logistical processes • Ensure the capture of synergies and best practices and avoid redundant activities and expenses particularly for new global sites • Contribute to Cell Chain development and other platforms for use by clinical and commercial and manufacturing teams • Lead and manage the global product allocation process • Implement activities related to forecasting and cell therapy production planning for clinical trials • Liaise with TRD and Planning and Scheduling for cell therapy shipments and mock shipments with clinical sites • Manage courier vendors as to facilitate shipping of apheresis and delivery of cell therapies, to ensure transport regulations are met • Provide clinical expertise on feasibility and qualification of apheresis sites and contracted cell processing lab • Develop and oversee baseline assessments for apheresis and cellular processing laboratories at clinical sites • Oversee and manage vendors/consultant(s) and site interactions by ensuring assessments are conducted • Serve as subject matter expert in the development of program specific standards related to cellular therapies
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
• University degree with an advanced degree in science preferred (e.g., MD, Pharm. D., PhD.)
• A minimum of 5+ years of pharma experience or at least 3 years pharmaceutical experience and experience in clinical stem cell transplantation
• Drug development experience, with deep understanding of submission requirements
• Commercial experience, or deep understanding of commercial model and strategy preferred
• Experience in start-up environment preferred
• Manufacturing / Logistics understanding/experience preferred
• Cell and Gene Therapies experience preferred
Novartis Technical Operations
NTO BTDM
USA
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time
Regular