Job Description 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.
In the role of Associate Director/Director PK/PD, you will collaborate with business partners in a cross-functional team to select and characterize new chemical entities, large molecules and cell/gene therapies from research and advance promising entities into the clinic. This unique role will provide matrix leadership to collaborate, align and influence across the cross-functional teams of medical experts, study leaders, pharmacokineticists, statisticians, pharmacometricians and outsourcing experts to identify and mitigate key project issues across therapy areas and implement strategies related to the pharmacokinetic sciences [PKS] discipline (PK, PK/PD, metabolism and clinical pharmacology).
Your major accountabilities will include:
• Representing the PK/PD/ADME and Clinical Pharmacology discipline, and serving as the primary source of scientific expertise on global cross-functional project teams, leading the design, execution and analysis of PKS preclinical and clinical studies, with focus on moving candidates from the discovery phase to clinics.
• Working with subject matter experts in PKS and partner groups, supporting the efficient application and integration of modeling and simulation tools to advance lead optimization and clinical candidate selection.
• Making use of PKS resources across NIBR organizations to drive project efforts; ensuring an aligned position on research strategy and in particular human PK/PD and dose projections as candidates transition into the clinic.
• Supporting PKS components of preclinical and clinical study protocol designs, preclinical and clinical study reports and investigator brochures, regulatory submission documents, etc.
• Preparing for Health Authority calls/meetings/discussions and acting as responsible PKS representative in these settings.
• Collaborating with other NIBR and GDD functions, bringing innovative ideas and approaches, and a leadership, enterprise mindset that informs and influences the overall drug discovery and development process.
• Representing PK Sciences as a discipline expert (Assoc. Dir.) or senior discipline expert (Director) to internal and external scientific communities.
• Authoring of key position papers or presentations to internal and external scientific meetings, consortia, regulatory agencies as appropriate (senior expert authoring at Director level).