Principal Scientist, PK Sciences Oncology-Radioligand Therapies (RLT)

90%! Is the percentage of our treatments in development with the potential to be first in class or first in a specific indication!<br>Novartis is deeply committed to transforming the lives of people living with solid tumors. We believe that anyone living with these conditions has the right to a life free from pain, free from symptoms and free from disease - this is our vision for the future.<br>Our mission is to reimagine medicine to extend and improve peoples lives – and our overall company strategy to achieve this is to Focus Novartis as a leading medicine company powered by data science and advanced therapy platforms such as Radioligand Therapy (RLT).<br><br>Novartis has become the industry leader in RLT after the acquisition of Advanced Accelerator Applications (AAA) and Endocyte in 2018, together with other significant investments to advance radioligand research. Novartis Oncology is now developing a wide range of targeted RLTs, and precision Radioligand Imaging (RLI) agents, for oncology with a rich pipeline targeting multiple tumor types through a phenotypic precision medicine approach.<br>Nuclear Medicine (NM) expertise is key for Novartis Oncology to expand RLT and supportive RLI agents in a sustainable manner.<br><br>The PK Sciences (PKS) team offers you a 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 Ophthamology) 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.<br><br>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 in RLT as part of the overall program(s).<br><br>Your major accountabilities will include but not be limited to: <br><br>• 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).<br>• 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. <br>• Work with subject matter experts in PKS and partner groups<br>• 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.<br>• 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. <br>• Responsible for the compilation, seeking of approval and updating of Line Function specific elements of development plans to support the TPP (Target Product Profile).<br>• Evaluate in-licensing opportunities and carry out Due Diligence activities as required.<br><br>The specific accountabilities of the role will be based on the stage of the program (preclinical or clinical) <br><br>The location of the position will be at our Cambridge, MA site and will not have the ability to be located remotely.<br><br>[#video#https://www.youtubeno-cookie.com/embed/5GPu2JoOzM4{#400,300#}#/video#]