Job Description Do you want to be at the forefront of the fight against multiple diseases making an impactful contribution in bringing transformative therapies to patients and be part of Novartis’ mission to reimagine medicine to improve and extend people’s lives?
PK Sciences (PKS) offers you this unique opportunity to make an impact where 450 projects are straddling discovery through development. PKS is a global organization of about 300 associates, within the Translational Medicine (TM) department, in Novartis Institutes of Biomedical Research (NIBR). It is an enterprise organization, unique to pharmaceutical industry, where you can work across both NIBR (Research) and the Global Drug Development (GDD) organizations to advance the scientific knowledge of pharmacokinetics, pharmacodynamics, metabolism and clinical pharmacology from discovery through approval and beyond. Novartis portfolio consists of projects in multiple therapeutic areas (Cardiovascular, Metabolic Diseases, Immunology, Hepatology, Dermatology, Oncology, Hematology, Neuroscience, Musculoskeletal Diseases, Respiratory, and Ophthalmology) using several therapeutic modalities including small molecules, biologics, gene therapy and cell therapy. 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.
In this role of Principal Scientist, you will collaborate with a cross-disciplinary team to select and characterize new chemical and biologic entities in research and development and implement clinical pharmacology strategies in early and late clinical development. You will represent the PK/PD/ADME discipline on discovery and development project teams, and suggest and implement strategies and tactics to advance high-quality entities as part of the overall program(s).
Major Accountabilities Include:
• The specific accountabilities of the role will be based on the stage of the program (preclinical or clinical)
• In this role you will provide matrix leadership to collaborate, align and influence across the cross-functional team to identify and mitigate key project issues related to the pharmacokinetic sciences discipline (PK, PK/PD, metabolism and clinical pharmacology).
• You will represent the PK/PD/ADME/Clinical Pharmacology discipline as per project need, and serve providing scientific expertise on global cross-functional project teams, leading the strategy, design, execution, and analysis of PKS preclinical and clinical studies.
• Working with subject matter experts in PKS and partner groups
• Support PKS components of preclinical and clinical study protocol designs, preclinical and clinical study reports, and investigator brochures, IND, NDA etc. Prepare for Health Authority calls/meetings/discussion and be responsible as PKS representative in these settings.
• Collaborate with other NIBR and GDD functions, bring innovative ideas and approaches, and a leadership, enterprise mindset that inform and influence the overall drug discovery and development process.
• Responsible for the compilation, seeking of approval and updating of Line Function specific elements of development plans to support the TPP (Target Product Profile).
• Evaluate in-licensing opportunities and carry out Due Diligence activities as required.