Immunomedics, Inc.

  • Director, Translational Science and Companion Diagnostic Development

    Job Locations US-NJ-Morris Plains
    Posted Date 2 months ago(10/10/2018 9:33 AM)
    Job ID
    2018-1346
    # of Openings
    1
    Category
    Clinical
  • Overview

    The core focus of the role is to support biomarker development and utilization for multiple exciting pipeline programs. This role will partner and work collaboratively with cross-functional team members to ensure alignment on project goals, milestones and deliverables.

    Responsibilities

    Design and deliver biomarker strategies to enable informed and efficient early clinical development

    Identify candidate pharmacodynamic and predictive biomarkers based on target biology, drug mechanism of action, and patient population

    Collaborate with project teams, external investigators and contract research organizations to evaluate candidate biomarkers in nonclinical models and patient samples and select optimal assays for clinical evaluation

    Drive efforts to evaluate and implement state of the art technologies for clinical biomarker studies

    Oversee development, qualification, and execution of innovative assays for clinical biomarker analysis internally and with contract research organizations

    Monitor ongoing biomarker assay quality and provide scientific review of data/reports

    Coordinate closely with Clinical Operations to develop clinical trial laboratory manuals, train clinical site staff, monitor sample collection and manage relationships with clinical trial site contacts

    Author relevant sections of clinical documents, regulatory submissions and publications

    Evaluate, interpret, and communicate clinical biomarker data to guide project decisions

    Function as an internal expert in oncology biomarkers and contribute to scientific discussions and engagement with key opinion leaders in the field

     

    Experience in companion diagnostic development sufficient to lead development with an external partner.

    Strong interpersonal skills with demonstrated ability to work well in a collaborative and dynamic team environment

    Strong analytical and problem-solving skills; ability to combine attention to detail with big picture perspective

    Excellent written and oral communication, including presentation, negotiation, team building, and facilitation skills

    Excellent organizational skills, able to work independently and proactively, prioritize and manage multiple tasks simultaneously

    Proven effectiveness in a quick-changing, fast-paced environment, a strong team player with high energy and a can-do attitude

    Qualifications

    PhD or PharmD in a health-related field.

    10+ years of experience in clinical trials and/or clinical assay development/management in a biotech or pharmaceutical setting

    Training and /or experience in Immunology, Immuno-oncology and/or Cancer Biology

    Experience in biomarker and/or genomic-related assay development or research in the pharmaceutical/biotech setting

    Knowledge and experience operating in drug discovery and development

    An understanding of clinical drug development and requirements for associated clinical assays

     

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