Job Opportunity - Senior Scientist, Global Clinical Pharmacology (Oncology), Janssen R&D

Dear nmusers: Janssen Research & Development, L.L.C., a Johnson & Johnson Company, is hiring a Senior Scientist, Global Clinical Pharmacology, Oncology TA in Spring House, PA. Please use this link to apply: https://goo.gl/Qd7HaQ The Senior Scientist, Global Clinical Pharmacology (GCP), Oncology (TA) role is to apply and promote Clinical Pharmacology knowledge, including pharmacokinetics/pharmacodynamics analyses 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 various stakeholders, QS-Project Matrix teams, Clinical Pharmacology Leader, and Pharmacometrics Leader. The Senior Scientist can also function as Clinical Pharmacology Leader on the Compound Development Team (CDT) and execute the day-to-day operations for the clinical pharmacology aspects of the assigned programs. The Senior Scientist, Global Clinical Pharmacology, Oncology TA will: * 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. With assistance from senior members, the Senior Scientist will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles. * Collaborate with Pharmacometrics (PM) Leaders on 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 to guide dose regimen from pre-proof of concept (POC) and POC studies * Collaborate with PM Leaders on the execution of 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 pharmacokinetics (PK) and PK/pharmacodynamics (PD), and (2) requirements for the clinical pharmacology regulatory submission packages and submission processes * Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles Qualifications: * PhD or PharmD required with a concentration in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences and at least 2 years of relevant experience is required * Understanding of PK, PD, PK/PD, and Translational Medicine is required * Ability to interpret PK and PKPD results and prepare presentations to illustrate findings accurately is required * Understanding of overall process of drug development and the overall pharmaceutical R&D process is required * Has established a level of expertise and scientific reputation through publications and/or presentations is required * Drug development experience in Oncology (preferred) or other Therapeutic Areas and the ability to handle contributions to multiple clinical pharmacology programs, simultaneously is preferred * Demonstrated understanding of model based drug development (MBDD), biopharmaceutics classification system (BCS), and biostatistics principles and tools (e.g., Gastroplus, Simcyp, Winnonlin, NONMEM) and demonstrated ability to apply these tools to enable rational and efficient drug development is preferred * Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s) is required Thanks, Tom. Yu-Nien (Tom) Sun, PhD Senior Director Global Clinical Pharmacology [Janssen_Hor_RGB] Janssen Research & Development 1400 McKean Road, PO Box 776 Spring House, PA 19477 Office: +1-215-793-7288 Cell: +1-215-360-4186 E-mail: [email protected]<mailto:[email protected]> ************************************************** Confidentiality Notice: