Job Description Requisition ID: 1420161128 (to apply, visit http://bit.ly/2fO9Dm1)
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting a Senior Scientist in Global Clinical Pharmacology to be located in: Raritan, NJ, or Spring House, PA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. 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<http://www.janssenrnd.com/> for more information. Objective of Position The position is responsible for the development and execution of Pharmacometrics (PM) activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication for products in any phase of development. Additional responsibilities include the generation and review of clinical pharmacology documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies and Advisory Committee Meetings. Main Accountabilities * Establish and elaborate pharmacometric strategies to support model informed drug development for projects at all stage of development * Execute pharmacometrics strategies by applying innovative methods to integrate data of pharmacokinetics, pharmacodynamics, biomarkers, clinical outcomes, patient characteristics, disease mechanisms and performing simulations to facilitate quantitative decision making * Interactive with multi-disciplinary project groups and work in close collaboration with partners in Clinical Pharmacology, Biostatistics and Programming, and Clinical * Author and review pharmacometrics-related sections in clinical development plan, study protocols, study reports, and regulatory communications * Maintains state-of-the art knowledge of modelling techniques and methodologies and establish scientific credibility in the company and in external scientific communities * Lead by example and coach Associate scientists, Sr. associate scientists and Scientists * Carry out functional responsibilities in accordance with applicable SOPs and Regulatory requirements * Support installation and validation of new and existing software used by Pharmacometrics * Assist in process improvement initiatives and SOP development Qualifications * Ph.D. Degree or equivalent, minimum 3 years of relevant experience is required or M.S. Degree, PharmD, or equivalent and at least 6 years of experience is required. * Excellent hands-on knowledge of data handling packages (SPLUS / R / SAS) is required * Proficient hands-on knowledge of Nonlinear Mixed effect modeling software packages is required. * A fundamental understanding of clinical drug development is required. * Understanding of ICH and other relevant regulatory guidelines and regulations is required. * This position is requiring up to 5% travel.
