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 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 across many different Disease Areas. 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 and GDD 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