Immunomedics, Inc.

  • Senior Clinical Scientist

    Job Locations US-NJ-Morris Plains
    Posted Date 6 days ago(12/3/2018 7:29 AM)
    Job ID
    2018-1378
    # of Openings
    1
    Category
    Clinical
  • Overview

    Immunomedics is actively recruiting for a Full Time Employee or Contract Permanent Sr. Clinical Scientist (CS), to provide scientific leadership for development and oversight of clinical studies.  The CS is responsible for supporting assigned drug development projects specifically with clinical documents and data review.  The CS serves as a key clinical resource for the assets in the pipeline. 

    Responsibilities

    • Contribute and author documents for IND/NDA/CTA and other regulatory documents (e.g. briefing documents, protocols, IBs)
    • Provide scientific and technical leadership for successful study-related documents and correspondence, ensuring each decision affecting study outputs are fully documented in accordance with relevant SOPs and compliant to regulatory review
    • Contribute 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, as appropriate
    • Provide study-related training and respond to protocol-related questions
    • Work with data management on case report form development and other data capture activities to ensure adequate data capture
    • Review study listings and provide the team with input
    • Look for trends with study data
    • Work closely with the Medical Monitor, Data management, Statistics, and the study lead
    • Experience in oncology data review
    • Experience with EDC to review Patient profiles and listings
    • Proficient in excel
    • Experience with MS word, power point and other tools

    Qualifications

    • BS degree required
    • Expertise with the clinical drug development and regulatory processes and understanding of the design and conduct of clinical trials
    • At least 10+ years of experience in the clinical sciences within Industry (pharmaceutical, Biotechnology)
    • Significant 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
    • Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs – integrating clinical science, disease area knowledge, and operational requirements
    • Strong presentation skills
    • Working knowledge of all relevant regulatory guidelines and standards (e.g. GCP, ICH, and FDA/EMA Guidance documents), as well as practices and expectations of Quality within GCP

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