• Assoc Director Clinical Pharmacology

    Job Locations US-NJ-Jersey City
    Job ID
    2018-1307
    # of Openings
    1
    Type
    Full Time Regular
    Category
    Product Development
    FLSA Status
    Exempt
    Work Shift
    N/A
  • Overview

    Responsible for providing support with regard to all aspects of Clinical Pharmacology including study planning, Pharmacokinetic (PK) analysis, and reporting for early and late stage clinical development plans in accordance to appropriate regulatory guidelines. Work with the regulatory team, project managers, data managers, biostatisticians, and other clinical research specialists to ensure accurate execution of research protocols in agreement with good scientific and clinical research practices, and in compliance with Noven standard operating procedures (SOPs) and other company procedures.  Review methodologies and data collection, perform analyses, interpret findings, and write reports for submission to the U.S. Food and Drug Administration (FDA).

     

    Assignment to the various levels is approved by Corporate Compensation and is based on the required knowledge in the field of work, years of experience, on-going responsibility for highly complex assignments, significance of the scope of responsibility, and the job function's considerable impact within the department and the company, as well as the reporting relationship and required supervisory responsibility.

    Responsibilities

    • Interact closely with internal team members, Contract Research Organization’s (CROs), partner organization scientists, and Noven management.
    • Design clinical pharmacology studies across stages of development. Perform non-compartmental and compartmental analysis of clinical data, as appropriate, and provide interpretation of PK and PK/PD results. Experience with WinNonlin is required.
    • Apply and interpret modeling and simulation approaches, including clinical trial simulations that will support study design and dose selection. Maximize the use of predictive tools for a more efficient and leaner clinical drug development. Experience with NONMEM/R and Monolix/SimCyp is preferred but not required.
    • Make major contributions to the clinical pharmacology and pharmacometrics strategy to meet corporate, scientific and regulatory needs as a member of appropriate project teams
    • Consistently mine scientific literature and information from scientific meetings to bring innovation into clinical trial study design and gather insights for life cycle management indications of existing molecules.
    • Prepare regulatory documents, including reports, protocols, investigator brochures, FDA communications, presentations, abstracts and other scientific documents. Provide clinical pharmacology support in response to regulatory agencies questions as needed
    • Assist in the evaluation of compounds proposed for incorporation into transdermal systems. Experience in developing transdermal formulations is preferred but not required.

    Qualifications

    Education & Experience:

    • in pharmaceutical sciences / pharmacokinetics or related field (M.D. a plus) and
    • 8 or more years of professional experience in the pharmaceutical industry in a clinical R & D organization
    • 2 years management experience. Knowledge of the Code of Federal Regulations (CFR), International Conference on Harmonisation (ICH), and Food and Drug Administration (FDA) regulations and guidance is a must.

    Work Environment:

    Majority of time spent in office environment, operating computer. 

     

    Physical Demands:

    Visual acuity and manual dexterity required to operate computer and proofread documents.

    Noven is an equal opportunity and affirmative action employer which recruits, hires, trains and promotes persons in all positions without regard to race, color, religion, sex, national origin, citizenship, disability, or veteran status or any other legally protected status.

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