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Senior Principal Scientist, PK Sciences Phase 1 Clinical Pharmacology (346048BR)

Science and Research

Scientist

Yearly

No

East Hanover, New Jersey, United States

450 projects straddle discovery through development. within PK Sciences @ NIBR. 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?<br><br>PK Sciences (PKS) offers you this opportunity to make an impact, 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.<br><br>In this role of Sr. Principal Scientist, you will provide scientific expertise to drive the success of fully outsourced clinical pharmacology studies by implementing strategies to achieve timely delivery of good quality clinically pharmacology data to support clinical development programs across all therapeutic areas and for regulatory submissions. Collaborate with internal project teams, clinical trial teams, and external CRO partners serving as a PK expert and liaison to deliver the Phase 1 clinical pharmacology portfolio.<br><br> Major Accountabilities Include:<br><br>• Represents PK Sciences (PKS) group in the clinical trial teams (CTT) comprised of medical, biostatistics, bioanalyst, clinical scientists, regulatory experts, and clinical supply managers, formed under Phase 1 Clinical Pharmacology Department (Phase 1 CPD).<br>• Oversees outsourced PK activities of Phase 1 trials - FIH, DDI, BA/BE, Human Mass Balance, Hepatic Impairment, etc..<br>• Drives fully outsourced project team’s PK strategy. Works globally across all therapeutic areas.<br>• Provides PK scientific leadership and expertise to all line functions on the CTT under Phase I Clinical Pharmacology Partnership (Phase 1 CPP) model. <br>• Responsible for review and finalization of study related clinical documents including protocol, Statistical Analysis Plans (SAP), and Clinical Study Report (CSR).<br>• Lead the oversight of PK data analysis, data interpretation with CRO partners and communication of the results internally.<br>• Oversee publication and external presentation of study results.<br>• With support from PK Project Team Member (PK PTM) and Therapeutic Area Heads (TA Heads), participate in selection of studies to be conducted under Phase 1 CPP model according to clinical pharmacology and profiling plan for the project.<br>• Together with the PK PTM may represent PK Sciences on Global Project Team (GPT) communications.<br>• Act as an effective sponsor representative to external partners on PK related questions and issues. <br>• Able to work independently on study planning and execution, and with collaboration on project planning.<br><br><br>Position can be based in East Hanover, NJ or Cambridge, MA<br><br>[#video# https://www.youtubeno-cookie.com/embed/4b_xZVjtpSE {#400,300#}#/video#]