• Associate Scientist

    Job Locations US-NJ-Princeton
    Requisition ID
    2018-10245
  • Responsibilities

    The Assoc. Scientist/Scientist, Pharmacometrics will perform high quality pharmacometrics (PMx) analyses essential for internal decision making and successful approval with the support of his/her supervisor. He/she will represent PMx in project and trial teams as well as author PMx reports and develop PMx strategy with the support of his/her supervisor.

     

    Job Responsibilities

    • Develop PMx strategy and contribute to the clinical development plan, and implement model-informed drug discovery and development (MIDD) in clinical development projects with support of supervisor.
    • Ensure timely delivery of PMx analyses for internal decision making throughout clinical drug development and registration with support of supervisor (e.g., non-linear mixed effects models, model-based meta analyses for dose selection, labeling, optimizing clinical study designs and pediatric development).
    • Ensure timely delivery of PMx internal documents with support of supervisor. (e.g., dataset specification, PMx analysis plan, and PMx report).
    • Ensure timely delivery of documents with support of supervisor. (e.g., clinical development plan, pediatric investigational plan, submission documents).
    • Represent PMx in clinical development teams and in initiatives and working groups with support of supervisor.
    • Organize and manage projects with external organizations with support of supervisor (e.g., academic institutions or CROs).

    Travel 20%

    Qualifications

    Knowledge

    • Minimum of 0-2 years (Associate Scientist) 2 - 5 years (Scientist) hands on experience as a pharmacometrician in pharmaceutical industry, regulatory agency, or academia.
    • Hands on modeling and simulation experience in PMx, PK/PD, clinical trial simulation and population based statistical analyses. 

    Skills

    • Must be able to apply scientific knowledge (in the areas specified above) to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.
    • Strong organization skills.
    • Strong communication skills.
    • Proficiency and ability to execute analysis in NONMEM and R
    • Knowledge of other PMx softwares such a Monolix, SAS, PKSim, MATLAB, SimBiology, SimCYP 
    • Knowledge in clinical pharmacology, clinical drug development, MIDD, and regulatory guidelines 
    • Flexibility to react rapidly to changing situations/environment

    Education and Related Experience

    • Ph.D. Degree in, Pharmacometrics, Clinical Pharmacology, Mathematics, Biology, Statistics or equivalent area of focus

    Overview

    Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.


    In pharmaceuticals, Otsuka is a leader in the challenging area of maental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.


    Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.


    All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

    Disclaimer

    Disclaimer:

    This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

    Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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