Janssen Research & Development, L.L.C., a Johnson & Johnson company, has several openings in Global Clinical Pharmacology (GCP) at our East Coast US locations (Spring House, PA, Titusville, NJ, or Raritan, NJ). We are seeking highly motivated individuals to join our group at Janssen at Scientist, Senior Scientist or Associate Director level. The individual is to apply and promote GCP knowledge, including pharmacokinetics (PK) and PK/pharmacodynamics (PD) analyses, translational modeling and principles of model-based drug development in the programs for all stages of drug development ranging from pre-New Molecular Entity (NME) declaration through Post-Marketing support, in collaboration with senior members of the group and various other stakeholders.
Main responsibilities include (based on experience): * Contribute to overall compound development via application of quantitative methods to integrate knowledge of PK, PD, patient characteristics, disease states, and drug-drug interactions to optimize dose selection, dosage regimens and study designs throughout drug development. Translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles. * Perform modeling and simulation activities in drug development programs. Perform and/or liaise for modeling and simulation analysis of preclinical-clinical data, translational PK/PD data, up to first-in-human (FIH) and if applicable beyond FIH (dose/exposure-response analyses, formulation and drug-drug interaction characteristics to guide dose regimen from pre-proof of concept (POC) and POC studies). * Develop protocol concepts for Clinical Pharmacology studies including drug-drug interaction studies, safety pharmacology studies and biopharmaceutics studies; perform analysis and interpretation of data from the studies and presentation of results to the project teams. Provide PKPD guidance to Phase 2-3 studies. An ideal candidate will have a doctoral degree (e.g., Ph.D.) in Pharmaceutics, Pharmacokinetics, Applied Mathematics, or Chemical and or Biomedical Engineering with keen interest in drug development, have an understanding of pharmacokinetics and pharmacodynamics principles, and have experience analyzing data describing biologic or PK/PD systems, preferably using a non-linear mixed effects modeling approach. Experience with computation software applications such as SimCYP, Gastro-Plus, R, MATLAB, SAS, NONMEM or similar software is desired. A job posting will be available at the ACoP7 meeting in Bellevue; for further details on the position please contact Daniele Ouellet at douel...@its.jnj.com<mailto:douel...@its.jnj.com>. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
