What are the responsibilities and job description for the Principal Scientist II, Clinical Pharmacology and Pharmacometrics position at Johnson & Johnson?
Johnson & Johnson Innovative Medicine is recruiting for a Principal Scientist II, Clinical Pharmacology and Pharmacometrics, located in Spring House, PA or Raritan, NJ with possibility of remote work option (within the US).
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, 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. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
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The Therapeutic Area (TA) Clinical Pharmacology (CP) Principal Scientist role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology knowledge, including the design of clinical pharmacology studies or clinical pharmacology component of clinical studies, pharmacokinetics/pharmacodynamics analyses and reporting, and application of principles of model-informed drug development (MIDD) within a program, with guidance from senior CPP leaders. With oversight, the Principal Scientist CPP can function as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various partners within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics) and implement the day-to-day operations for the clinical pharmacology aspects of the assigned programs. Programs can be across all stages of drug development ranging from pre-New Molecular Entity (NME) declaration through Post-Marketing support.
Key Responsibilities:
- Contribute to overall compound 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 patient sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development. Translate quantitative knowledge into strategic opportunities with to drive development along the model-informed 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 PK/PD analyses with respect to their impact on a development program and clinical use.
- Design and implement scientifically robust and efficient clinical pharmacology strategies for development candidates.
- Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
