J&J Family of Companies Senior Scientist Immunology – CPP in Raritan, New Jersey
The Immunology Senior Scientist role within Clinical Pharmacology and Pharmacometrics (CPP) is to apply and promote Clinical Pharmacology knowledge, including pharmacokinetics/ pharmacodynamics analyses and principles of model-based drug development in the programs across all stages of drug development ranging from New Molecular Entity (NME) declaration through Post-Marketing support, in collaboration with various partners, QS-Project Matrix teams, CPP Leaders, and Pharmacometrics Leaders. With oversight, the Scientist may also function as CPP Leader on the Compound Development Teams (CDT) and execute the day-to-day operations pertaining to all aspects of clinical pharmacology.
Accountabilities with assistance from senior members of the group:
Contribute to overall compound development strategy 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 Scientist will translate quantitative knowledge into strategic opportunities with key stakeholders to drive development that embodies the model-based drug development principles.
Plan and perform appropriate analysis (e.g., non-compartmental, population and/or modeling and simulation analysis of PK and/or PD data) of preclinical-clinical translation, dose/exposure-response relationships, to guide dose regimen and optimize study design.
Summarize and provide interpretation of results of PK and PKPD analyses with respect to their impact on a development program and clinical use.
Design and execute scientifically robust and efficient clinical pharmacology strategies for Immunology development candidates.
Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
Other Accountabilities & Tasks
Plan and conduct PK and PK/PD analyses, provide independent QC, and report results in appropriate format (e.g., team presentations, memo, CSR).
Design Phase I clinical pharmacology studies and clinical pharmacology components of clinical studies.
Handle operational elements of CPP studies.
Perform literature searches and summarize the findings.
Contribute to preparation of IB, INDs, briefing books, submission package, and other regulatory documents as applicable to support clinical studies and/or programs.
Expand knowledge of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modeling and simulation by engaging with the scientific community (e.g., publishing, speaking publicly at meetings, participating in special interest groups within professional societies, etc.) and internalize key takeaways back to Janssen.
Requires Product Development experience with a proven track record of accomplishment: direct association with or leading efforts to develop technically complex products from concept to market
Apply appropriate regulatory (eg: FDA, EMEA, ICH etc) guidelines in the design of clinical development plans and studies.
Apply relevant technical trainings/takeaways to daily responsibilities, with focus of opportunistic delivery of value/impact.
PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 3+ years of relevant experience (including postdoctoral studies)
Minimum Technical Knowledge and Skills
Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine.
Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab).
Understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process.
Working knowledge of US, European, and Asian (including BRIC countries) regulatory requirements and guidelines.
Good oral and written communication skills, including ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively.
Has established a level of expertise and scientific reputation through publications and/or presentations.
Estimated both domestic and international travel of about 5% of time.
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House
Janssen Pharmaceutica N.V. (7555)
J&J Family of Companies
- J&J Family of Companies Jobs