Principal Scientist, Clinical Pharmacology & Pharmacometrics

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Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Discovery & Pre-Clinical/Clinical Development

Pharmacokinetics & Pharmacometrics

Scientific/Technology

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

We are searching for the best talent for our Principal Scientist Clinical Pharmacology & Pharmacometrics position, to be located in Raritan, NJ;
Titusville, NJ; or Spring House, PA.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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The Clinical Pharmacology (CP) Principal Scientist role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology expertise including the design of clinical pharmacology studies and/or clinical pharmacology components of clinical studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis and reporting, and application of model-informed drug development (MIDD) principles across all stages of drug development. The Senior Principal Scientist CP Leader develops compound-specific Clinical Pharmacology strategies for supported programs, including interactions with regulatory agencies, and serves as the CP Leader on cross-functional compound teams and within CPP (e.g., Pharmacometrics).

The Senior Principal Scientist independently leads the day-to-day clinical pharmacology activities for programs within the Portfolio and Lifecycle Management (PALM) organization, focused on established brands and post-approval development opportunities.

• Devising the clinical pharmacology and model informed drug development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape, and drug interactions to influence go/no go decisions, support sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development.
  
  Translate quantitative knowledge into strategic opportunities to influence development along the model-informed drug development principles.
• Planning and performing, or providing oversight, for appropriate analyses (e.g., non-compartmental, population and/or modelling and simulation analysis of PK and/or PD data) of preclinical-clinical translation and dose/exposure-response relationships, to guide dose regimen and optimize study design.
• Planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.
• Planning and delivery of scientifically robust and efficient clinical pharmacology strategies for development candidates.
• Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
• Planning, conducting, and/or providing oversight of PK and PK/PD…