Immunomedics, Inc.

  • Senior Clinical Scientist

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(7/9/2019 2:56 PM)
    Job ID
    2019-1469
    # of Openings
    1
    Category
    Clinical
  • Overview

    The Clinical Scientist will provide scientific leadership for development and oversight of clinical studies (including documentation and data review). The Clinical Scientist serves as a key clinical resource for the assets in the pipeline and will be assignment to support specific development projects.   

    Responsibilities

    • Contributes and authors documents for IND/NDA/CTA and other regulatory documents (e.g. briefing documents, protocols, IBs).
    • Provides scientific and technical leadership for successful study-related documents and correspondence; ensuring each decision affecting study outputs is fully documented in accordance with relevant SOP’s and compliant with regulatory review.
    • Contributes in writing protocol, synopsis, IB and other study related documents.
    • Responsible for appropriate communication of study progress and deliverables to the project team or senior management.
    • Provides study-related training and responds to protocol related questions.
    • Works with data management on case report form development and other data capture activities.
    • Reviews study listings and provides the team with input.
    • Identifies trends with study data.
    • Works closely with the Medical Monitor, Data Management, Statistics, and the Study Lead.

    Qualifications

    • Bachelor degree in science or equivalent required. Master’s degree, Ph.D., Pharm. D. preferred.
    • 7 + years of experience in clinical sciences within pharmaceutical/biotechnology industry.
    • Experience in oncology data review.
    • Experience with EDC to review patient profiles and listings.
    • Expertise with clinical drug development and regulatory processes and understanding of the design and conduct of clinical trials.
    • Experience in data review, listings via EDC and other platforms (J review etc.) preferred.
    • Ability to interface professionally with a wide spectrum of internal and external academicians, agencies and industry stakeholders in the scientific/clinical development arena.
    • Ability to work on multiple projects with aggressive timelines.
    • Ability to work independently with minimal supervision.
    • Strong interpersonal and communication skills bridging scientific and business needs-integrating clinical science, disease area knowledge and operational requirements.
    • Working knowledge of all relevant regulatory guidelines and standards (e.g. GCP, ICH, and FDA/FEMA guidance documents) as well as practices and expectations of Quality within GCP.
    • Proficiency in Word, Excel and Power Point.
    • Strong problem solving and critical thinking skills.
    • Strong organization skills and attention to detail.
    • Strong presentation skills.

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