Novartis Pharmaceuticals Project Team Member PK Sciences, Gene Therapy Support in Cambridge, Massachusetts
6000! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.
PK Sciences (PKS) is a global organization of about 300 associates, within NIBR, Novartis’s Research Organization. Although PK Sciences is part of NIBR, we provide nonclinical and clinical PK/PD/IG/ADME support to all stages of Drug Development, from the very early stages of Discovery through Post-Market for all modalities (LMW, Biologics, Cell Therapies, and Gene Therapies).
We are seeking a project team member to join the PKS Gene Therapy team at the Cambridge, MA location. As an individual contributor in this role you will collaborate with other Line Functions to select and characterize the biodistribution, shedding, and immunogenicity of new AAV-based Gene Therapies for advancement into the clinic, characterize their properties in clinical trials, and create documents for Regulatory submissions. As a project team member you will represent the PKS discipline on project teams, contributing to the creation and implementation of the project-specific strategies and tactics. You will also support projects in both the Novartis and AveXis portfolios. In addition to the development of Novartis’s own drugs, you will participate in Due Diligence activities to evaluate potential external business opportunities.
Your main responsibilities will include but not be limited to:
• Represent the PKS discipline, and serve as the primary source of scientific expertise regarding biodistribution, shedding, and immunogenicity on global cross-functional project teams, leading the design, execution, and analysis of PKS nonclinical and clinical studies.
• Work with subject matter experts in PKS and partner groups, support the efficient application and integration of modelling and simulation tools to advance serotype and dose selection.
• Utilize resources within PKS and across NIBR, GDD and AveXis to ensure a robust assessment of biodistribution, shedding, and immunogenicity is made.
• Provide input on biodistribution, shedding, and immunogenicity to nonclinical and clinical study protocols, nonclinical and clinical study reports, and documents for Regulatory Submission (e.g. Investigator Brochures, nonclinical PK and clinical pharmacology summaries etc). Participate in meetings with Health Authorities and contribute to Due Diligences.
• Contribute to the development of Novartis’s strategy for the assessment of biodistribution, shedding, and immunogenicity for AAV-based Gene Therapies
• Contribute to the design and conduct of platform studies to enhance our understanding of the biodistribution, shedding, and immunogenicity of AAV-based Gene Therapies
Project Team Member PK Sciences, Gene Therapy Support
What you will bring to the role:
• PhD in immunology, gene therapy or related sciences.
• Good understanding of the drug discovery and development process, with 3+ years in pharma/biotech industry.
• Experience in the development of AAV-based Gene Therapies by multiple routes of administration (e.g. subretinal, intravitreal, IV, IT, ICM).
• Expertise in the assessment of the biodistribution, shedding, and immunogenicity of AAV Gene Therapies.
• Experience in authoring regulatory documents, knowledge of global regulatory requirements and guidances desired.
• Excellent written and oral communication skills is a must.
WHY CONSIDER NOVARTIS?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Research & Development
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