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.

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/

• 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.

• A minimum of a Master's or PharmD degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or related Biological Sciences discipline is required. Ph.D. in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or related Biological Sciences discipline is preferred.
• A minimum of 3 years of relevant experience with a Master's or PharmD degree or a minimum of 2 years of relevant experience (including postdoctoral studies) with a Ph.D. is required.
• Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine is required.
• Understanding of advanced analysis methods (e.g., population analysis, physiologically based pharmacokinetic (PBPK), quantitative systems pharmacology (QSP)) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab) is required.
• Understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process is required.
• Working knowledge of U.S., European, and Asian (including BRIC countries (Brazil, Russia, India, China)) regulatory requirements and guidelines is preferred.
• Established level of expertise and scientific reputation through publications and/or presentations is preferred.
• Must have excellent oral and written communication skills.
• Must be a self-motivated team player who excels in a collaborative, multi-disciplinary team environment.
• The ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively is required.
• The ability to interact and collaborate effectively in matrix environment is required.

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year