Immunomedics, Inc.

  • Clinical Development, MD

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(9/4/2018 4:16 PM)
    Job ID
    2018-1299
    # of Openings
    1
    Category
    Clinical
  • Overview

    Immunomedics is a leading, innovative biopharmaceutical company dedicated to improving the health and quality of life with novel Immunotherapeutics for the treatment of cancer, autoimmune and other serious diseases.   Our work is driven by scientific excellence and the highest standards, in a culture of integrity, pride and dedication. In doing so, we create value for our shareholders and a rewarding environment for our employees.   In pursuit of excellence we are expanding our clinical development team with top-notch talent to support a compound with significant potential in both liquid and solid tumors.

    Responsibilities

    • Collaborate with a growing Clinical Development Team with responsibility for assigned clinical trial program.
    • Supports the clinical development strategy for one or more indications including successful regulatory submission
    • Designs and optimizes clinical protocols and trial design
    • Works with clinical scientist in overseeing the quality, coordination and timeliness of protocol development
    • Guides the work of clinical study managers and is responsible for quality and timeliness of study execution
    • Medical review and interpretation of efficacy and safety data
    • Assures quality, coordination, medical accuracy and timeliness of clinical study reports
    • Collaboratively prepares abstracts, manuscripts and presentations for external meetings, and authors clinical sections of regulatory documents (IB, IND sections)
    • Supports colleagues in overseeing preparation of clinical sections of INDs, IBs, CTAs, ISS’s, and clinical expert reports
    • Presents data and findings at meetings (internal, DSMC, KOL and investigator meetings)
    • Establishes and fosters effective working relationships with study investigators, KOLs, academicians and internal colleagues
    • Ensures adherence to GCP/ICH and AAA SOP standards
    • Maintains current knowledge of clinical and scientific developments

    Qualifications

    • Education: D.  Boarded (or Board eligible); heme/onc experience a plus
    • Therapeutic or disease area sub-specialty or certification a plus)
    • 3 years clinical medicine experience and 2+ years in pharma/biotech or equivalent clinical trial experience in academia
    • Solid understanding of drug development process
    • Working knowledge of GCP, FDA regulations/guidelines, and applicable international regulatory requirements
    • Clinical trial design experience
    • Ability to provide scientific/clinical expertise to clinical development program
    • Strong interpersonal, communication (written and verbal) and presentation skills
    • Effective leadership, organizational and project management skills

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