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Career Opportunity - Senior Scientist, Clinical Pharmacology and Pharmacometrics at Janssen (Johnson & Johnson)

From: Y Z <ylzh2005>
Date: Tue, 23 Apr 2019 13:21:28 -0400

*Position: Sr. Scientist, Clinical Pharmacology and Pharmacometrics *

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is
hiring a Sr. Scientist, Clinical Pharmacology and Pharmacometrics (CPP) -
Immunology TA, in Spring House, PA.

*Job Description:*

The Clinical Pharmacology and Pharmacometric (CPP) Department of Janssen
Research & Development, L.L.C., a Johnson & Johnson company, is seeking a
highly motivated individual to join Clinical Pharmacology (CP) Immunology
group at Senior Scientist level. This individual is to apply and promote
CPP knowledge, including pharmacokinetics (PK)/ pharmacodynamics (PD)
analyses, translational modelling and principles of model-based drug
development in the programs for all stages of drug development ranging from
pre-New Molecular Entity (NME) declaration through Post-Marketing support,
in collaboration with various stakeholders, Quantitative Sciences
(QS)-Project Matrix teams and Pharmacometrics (PM) Leader. Depending on the
experience, this individual may function as a CP Leader on the Compound
Development Team (CDT) and execute the day-to-day operations for the
clinical pharmacology aspects of the assigned programs.
  Main Accountabilities (based on experience)

   - Contribute to overall compound development 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. Translate quantitative knowledge into strategic opportunities
   with key stake holders to drive development along the model-based drug
   development principles.
   - Perform modeling and simulation activities in drug development
   programs. Perform and/or liaise for modeling and simulation analysis of
   preclinical-clinical data, translational PK/PD data, up to first-in-human
   (FIH) and if applicable beyond FIH (dose/exposure-response analyses to
   guide dose regimen from pre-proof of concept (POC) and POC studies).
   Provide PKPD guidance to Phase 2-3 studies.
   - Execute scientifically robust and efficient clinical pharmacology
   strategies for NME and/or development candidates.
   - Applies the understanding of (1) the impact of intra- and
   inter-subject variability in physiology and/or pathology, concomitant
   medication use, and biopharmaceutics, on PK and PK/PD, and (2) requirements
   for the clinical pharmacology regulatory submission packages and submission
   - Represent clinical pharmacology function in multi-disciplinary
   clinical teams.
   - Carries out functional responsibilities in accordance to applicable
   SOPs, regulatory requirements and Johnson & Johnson Credo principles.

Other Accountabilities & Tasks (based on experience)

   - Help design and execute PK, PK/PD modeling efforts to address the
   unique challenges pertinent to the project.
   - Manage operational elements of Clinical Pharmacology studies.
   - Perform literature searches and summarize the findings.
   - Contribute in monographs, INDs and other documents as applicable to
   support clinical studies and regulatory filings (e.g. NDA/BLA).
   - Represent Clinical Pharmacology Function in the regulatory meetings
   (e.g. pre-IND, EoP1, EoP2, NDA/BLA filing etc.) with the assistance of the
   senior member as appropriate.
   - Remain current with clinical and drug development information 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.
   - Support CP and PM Leaders with ad hoc analyses, not limited to
   non-compartmental analyses in support of Phase I studies
   - 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.


   - PhD or equivalent degree in Pharmaceutical Sciences, Clinical
   Pharmacology, Biomedical Engineering, or relevant Biological Sciences of
   relevant experience OR MS or PharmD degree or equivalent, with a minimum of
   2 years of relevant experience, with keen interest in drug development.
   - Understanding of PK, PD, PK/PD, and Translational Medicine.
   - Have experience analyzing data describing biological or PK/PD systems,
   preferably using a non-linear mixed effects modeling approach.
   - Ability to interpret PK and PK/PD results and prepare presentations to
   illustrate findings accurately.
   - Understanding of overall process of drug development and the overall
   pharmaceutical R&D process.
   - Has established a level of expertise and scientific reputation through
   publications and/or presentations.
   - Drug development experience in Immunology (preferred) and/or other
   Therapeutic Areas and the ability to handle contributions to multiple
   clinical pharmacology programs, simultaneously.
   - Demonstrated understanding of model-based drug development,
   biostatistics principles and modelling tools (e.g., NONMEM, R, Phoenix
   NLME, R, SimCYP, Gastro-Plus, MATLAB, SAS, or similar software) and
   demonstrated ability to apply these tools to enable rational and efficient
   drug development.
   - Working knowledge of clinical and regulatory landscape, disease
   processes and mechanisms, available treatment paradigms, and patient
   populations within assigned Therapeutic Area(s).

If you are interested in this position, kindly email your CV to

Received on Tue Apr 23 2019 - 13:21:28 EDT

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