Principal Scientist, Pharmacokinetics and Pharmacometrics

Company: Disability Solutions
Location: Spring House
Posted on: February 2, 2025

Job Description:

Johnson & Johnson Innovative Medicine R&D is recruiting for a Principal Scientist, Clinical Pharmacokinetics and Pharmacometrics. The preferred location for this position is Spring House, PA. Alternate locations are Titusville, NJ or Raritan, NJ.\rAt 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/\rFor 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.\rWe 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.\rAt Johnson & Johnson, we all belong.\rThe Principal Scientist role within Clinical Pharmacology and Pharmacometrics (CPP) will 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 will function as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various stakeholders within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics) and execute 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.\rPrincipal Responsibilities:

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• Contribute to overall compound development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), Pharmacokinetics (PK), Pharmacodynamics (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 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 execute scientifically robust and efficient clinical pharmacology strategies for development candidates.
• Carries out functional responsibilities in accordance to applicable Standard Operating Procedures (SOPs), regulatory requirements and Johnson & Johnson Credo principles.
• Plan and conduct PK and PK/PD analyses, provide independent Quality Control (QC), and report results in appropriate format (e.g., team presentations, memo, clinical study report).
• Design Phase I clinical pharmacology studies and clinical pharmacology components of clinical studies.
• Manage operational elements of CPP studies.
• Perform literature searches and summarize the findings.
• Contribute to preparation of Investigator's Brochure (IB), Investigational New Drugs (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, presenting at meetings, participating in special interest groups within professional societies, etc.) and internalize key learnings back to Janssen.
• Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
• Apply appropriate regulatory (e.g., FDA, EMEA, ICH, etc.) guidelines in the design of clinical development plans and studies.
• Apply relevant technical trainings/learnings to daily responsibilities, with focus of opportunistic deliver of value/impact.\r\r

Keywords: Disability Solutions, East Orange , Principal Scientist, Pharmacokinetics and Pharmacometrics, Other , Spring House, New Jersey