Position: Scientist/Sr. Scientist, Clinical Pharmacology and Pharmacometrics
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is hiring a Scientist or Sr. Scientist, Clinical Pharmacology and Pharmacometrics (CPP) - Immunology TA, in Spring house PA.
This individual is to apply and promote CPP knowledge, including pharmacokinetics (PK)/ pharmacodynamics (PD) analyses, translational modelling 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.
Depending on the experience, this individual may function as a 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.
Qualifications:
*Have a doctoral degree (PhD or equivalent) in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences. OR Have a PharmD degree or equivalent with a minimum of 1 year of relevant experience.
*Understanding of PK, PD, PK/PD, and Translational Medicine is required.
*Have experience analyzing data describing biological or PK/PD systems, preferably using a non-linear mixed effects modeling approach.
*Ability to interpret PK and PK/PD 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.
*Established a level of expertise and scientific reputation through publications and/or presentations.
*Drug development experience in Immunology (preferred) and/or other Therapeutic Areas and the ability to handle contributions to multiple clinical pharmacology programs, simultaneously.
*Demonstrated understanding of model-based drug development, biostatistics principles and modelling tools (e.g., NONMEM, R, Phoenix NLME, R, SimCYP, Gastro-Plus, MATLAB, SAS, or similar software) and demonstrated ability to apply these tools to enable rational and efficient drug development.
*Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s).
Interested candidates kindly email your CVs to "yxu115_at_its.jnj.com".