Senior Scientist, Clinical Pharmacology Opening at Johnson & Johnson

Dear all, Johnson & Johnson is looking for a Senior Scientist, Clinical Pharmacology to join the Team, located in Spring House, PA. Do you have Understanding of PK, PD and PK/PD? Are you interested in Model Informed Drug Development? This may be the role for you! Share, Contact Me or Apply: https://jobs.jnj.com/jobs/2105888522W?lang=en-us&previousLocale=en-USply: https://jobs.jnj.com/jobs/2105888522W?lang=en-us&previousLocale=en-US Key Responsibilities: * 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. * Collaborate with pharmacometric leaders on modeling and simulation activities in drug development programs. Perform and/or liaise for modeling and simulation analysis of preclinical and/or clinical data. * Execute scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates. * Applies the understanding of (1) the impact of intra- and inter-subject variability in physiology and/or pathology, concomitant medication use, and biopharmaceutics, on PK and PK/PD, and (2) requirements for the clinical pharmacology regulatory submission packages and submission processes. * Represent clinical pharmacology function in multi-disciplinary clinical teams (depending on experience). * Represent Clinical Pharmacology Function in the regulatory meetings (e.g. pre-IND, EoP1, EoP2, NDA/BLA filing etc.), with the assistance of the senior member as appropriate. * Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles Qualifications: * PhD or equivalent advanced degree is required, in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering/Bioinformatics, or relevant Biological Sciences, with a minimum of 2 or more years of post-graduate relevant experience, with a keen interest in drug development. * Working knowledge of small and/or large molecule drug development. * Drug development experience in Immunology (preferred) and/or other Therapeutic Areas. * Have experience analyzing data describing biological or PK/PD systems, preferably using a non-linear mixed effects modeling approach. * Understanding of model-based drug development, biostatistics principles and modelling tools (e.g., NONMEM, R, Python, Phoenix NLME, SimCYP, Gastro-Plus, MATLAB, SAS, or similar software) and the ability to apply these tools to enable rational and efficient drug development * Good written and communication skills. Thanks, Yan Xu, Ph.D Clinical Pharmacology and Pharmacometrics Janssen R&D - Pharmaceutical companies of Johnson & Johnson [email protected] www.janssen.com