US-NJ, Global Clinical Apheresis Leader 224555BR-MZ
Global Clinical Apheresis Leader
Global Drug Development
East Hanover, NJ
Research & Development
The GCAL is the clinical lead for the apheresis programs in the Cell and Gene therapy unit to ensure optimal cell product available for manufacturing cell products. The GCAL is responsible for the creation of apheresis strategy, guidelines and the clinical aspects of site training and certification for trial and commercial apheresis sites. The GCAL may also support sites on clinical issues related to infusion and may support the GCPH on other clinical initiatives.
1. Lead clinical aspects of apheresis strategies for CGTU products including the development of critical quality attributes and product specifications for apheresis optimization
2. Provide clinical expertise on identification of centers of excellence for apheresis/cell processing
3. Lead correlative analyses to characterize starting material, manufactured product and clinical outcome.
4. Provide clinical support for baseline assessments of apheresis and cellular processing laboratories.
5. Work with external and internal opinion leaders to incorporate advances and learnings into the apheresis process
6. Represent apheresis team at GCTs and GPTs when required
7. Serve as ultimate point of contact for resolution of clinical questions related to trial or commercial queries related to apheresis
8. Train clinical logistics leads and Novartis site support on clinical aspects of apheresis
9. Leads development of clinical sections of apheresis training materials and protocols
lO.Leads development of clinical sections of program level regulatory documents including protocols and submission documents
ll.Contribute to Cell Chain development and other platforms for use by clinical and commercial and manufacturing teams
12.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.
MD required, more than 5 years experience in relevant subspecialty (hematology, oncology, immunology)
3 years experience in stem cell transplantation
3 years experience in drug development
Commercial experience, or deep understanding of commercial model and strategy preferred
Experience in start-up environment preferred
Manufacturing I Logistics understanding/experience preferred
Cell and Gene Therapies experience preferred
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