Dear NMusers,
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting a Senior Scientist Global Clinical Pharmacology to be located in Spring House, PA. Please apply at the following link:
https://goo.gl/zUW7ve
The Senior Scientist Global Clinical Pharmacology (GCP) role is to apply and promote GCP 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, GCP and PM Leaders. With oversight, the TA Scientist GCP can also execute the day-to-day operations for the clinical pharmacology aspects of the assigned programs.
The Senior Scientist, GCP can directly impact the operational results, as they are focused on investigation and characterization of how drugs interact with biological systems or diseases so they can be used safely and effectively, and with the appropriate pharmaceutical formulation. As a Senior Scientist, main responsibilities include:
* 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 TA Scientist GCP will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles
* Assist GCP and PM Leaders with 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)
* Assist GCP and PM Leaders with the execution of scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates
* Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles
The ideal candidate will have:
* Ph.D. in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences with a minimum of 2 years of relevant experience OR PharmD in these fields with a minimum of 3 years of relevant experience is required
* Understanding of PK, PD, PK/PD, and Translational Medicine is required
* Modeling experience is required (e.g., NONMEM)
* 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 preferred
* 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., NONMEM, Winnonlin, Gastroplus, Simcyp) and demonstrated ability to apply these tools to enable rational and efficient drug development is preferred
Daniele Ouellet, PhD
Senior Director, Global Clinical Pharmacology