• Job Description

  Req#: 383405BR
  PK Sciences (PKS) offers you this opportunity to make an impact, where 450 projects are straddling discovery through development. PKS is a global organization of about 300 associates, situated within Translational Medicine (TM), in Novartis Institutes of Biomedical Research (NIBR). It is an enterprise organization, unique within pharmaceutical industry, where one can work across both NIBR (Research) and the Global Drug Development (GDD) organizations to apply the scientific knowledge of pharmacokinetics, pharmacodynamics, metabolism and clinical pharmacology in advancing the drug candidates from discovery and clinical development through approval and beyond. Novartis portfolio consists of projects using several therapeutic modalities including small molecules, biologics, gene therapy and cell-based therapies. We are active in multiple therapy areas like Oncology, Autoimmune Diseases, Neuroscience, Musculoskeletal Diseases, Ophthalmology, Respiratory, Cardio-metabolic and Infectious diseases. We collaborate across scientific and organizational boundaries, with a focus on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.
  
  Your responsibilities include, but are not limited to:
  
  • Manage all aspects of assay outsourcing at CRO which includes, contract review, assay development, validations in support of clinical trials for biologics . Coordinate and monitor PK, PD, anti-drug (ADA) and neutralizing antibodies (nAb) assay analysis activities during clinical trials ensuring accurate and timely data delivery.
  • Support emerging new modalities such as oligonucleotides and Cell and Gene therapies platforms. Act in the liaison between clinical teams and CROs, be a representant for clinical outsourced biologics to ensure alignment of study objectives, timelines, and deliverables.
  • Act as scientific leaders with our CRO partners; focusing on the fundamental science providing bioanalytical assays that answer emerging scientific questions during trials.
  • Coordinate project support and planning of lab resources, ensuring high quality data delivery within timelines in support of global Bioanalysis teams and other stakeholders
  • Contribute to the clinical bioanalytical strategy considering state-of the art technology and current health authority guidelines.
  • Review and interpret PK, PD, and immunogenicity data, providing insights and recommendations to support clinical development strategies. Provide technical and scientific oversight of external development and implementation of regulated immunogenicity and molecular biology assays.
  • Provide consultation and technical support for clinical Immunogenicity strategy discussions within Global Bioanalysis, and data interpretation consistent with current industry and health authority expectations.
  • Contribute to relevant bioanalytical sections to regulatory and submission documents (e.g. IB, CTD, BLA, ISI). Stay updated with the latest scientific advancements and industry trends related to PK, PD, and ADA analysis for biologics
  
  
  

• About the company

  At Novartis, we are reimagining medicine to improve and extend people’s lives. We are working hard to produce breakthroughs and address unmet needs for patients with devastating diseases, including genetic disorders and certain deadly cancers. Learn mo...

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