Advaxis

  • Director, Biomarkers

    Job Locations US-Princeton
    Posted Date 1 month ago(10/19/2018 5:31 PM)
    ID
    2018-1130
    # of Openings
    1
    Category
    Biotech/Pharmaceuticals
  • Overview

    Advaxis Inc. is an immunotherapy company located in Princeton, NJ that develops products based on a proprietary live-attenuated vector technology to develop immunotherapies for cancer. Our programs encompass a late stage product in HPV+ associated cancers, ongoing programs in prostate cancer, and our future focus on neoantigen targeting immunotherapies. Our highly innovative and differentiated ADXS-NEO program provides individual neoantigen-targeted treatments based on identification of a patients’ own specific mutations identified from whole exome sequencing of tumor DNA. This program is already in the clinic and has been partnered with Amgen. Our ADXS-HOT programs employ multiple cancer type specific, “off-the-shelf” mutational hotspot-targeting immunotherapies. This first IND under our HOT program has been allowed for our non-small lung cancer (NSCLC) drug candidate and the first patient is expected to be dosed by the end of this year. We have several other drug candidates from the HOT program for prostate, bladder and other cancers at various stages behind the NSCLC drug candidate.
    The challenge of immune monitoring and biomarker evaluation for neoantigen-based treatments is quite unique, and a critical pharmacodynamic index of treatment effects and this role will be at the center of the data generation and analysis efforts correlated with clinical treatment outcomes. We are seeking a highly motivated individual to join us as Director, Biomarkers. You will collaborate with the Research and Development and Clinical Development teams in this critical translational role in the exciting new area of cancer immunotherapy. Under minimal supervision, the successful Director candidate will be expected to develop immunologic monitoring and biomarker plans in collaboration with the research and development and clinical operations, assist in protocol development and site training, identify and vet third party laboratory service vendors, coordinate and oversee the collection, transport and analyses of clinical specimens for clinical trials organize and analyze results, coordinate the development of laboratory manuals, participate in the analysis and interpretation of immunologic and correlative findings, and communicate findings internally and at scientific meetings. You will also be asked to perform other duties as required. In this role you will report to the Chief Scientific Officer, with accountability to the Senior Director R&D, the Chief Medical Officer, and the clinical operations team.

    Responsibilities

    Provide biomarker operational expertise and guidance to cross-functional teams:

    • Track and ensure the timely and efficient delivery of all Immune Monitoring and Biomarker operational aspects of clinical studies, including Advaxis sponsored and academic collaboration studies across all stages (start-up,    conduct and close-out), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations. Provide regular updates to management.
    • Review and edit accurate technical documents including SOPs, qualification/validation protocols, drafting and editing of clinical trial protocol sections and reports
    • Manage the transfer and validation of methods to contract-testing labs where needed
    • Establish a cross-trial database of immunologic monitoring and biomarker data that can be DCIS compliant in a cost-effective manner
    • Support the development of the biomarker analysis budget and manage it for each protocol, communicating variances to management as appropriate.
    • Establish biomarker sample analysis and data delivery milestones and ensure accurate tracking and reporting of Biomarker sample metrics.
    • Establish and maintain a database of immunologic monitoring and biomarker database. Prepare data packages and other reports for publication, presentation and/or submission to regulatory agencies

    Contribute to the selection and implementation of new assay platform technology capabilities


    Contribute to company-wide scientific discussions, and bring new ideas to the table


    Other duties as assigned

    Qualifications

    Graduate education (M.S., Ph.D.) in immunology or a closely-related field and at least 3 years of relevant industry experience in cellular and/or tumor immunology

    A strong background in cancer biomarkers and/or immunotherapy and immunologic monitoring

    Strong organizational, record-keeping, and medical writing

    Experience with assay development, validation and analysis across relevant diagnostic technologies

    Familiarity with the conduct of clinical trials, specimen collection, and operational tracking

    Current knowledge of emerging correlative technologies (i.e., Digital PCR, RNA expression profiling, single cell sequencing, CF-DNA, etc.) 

    Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

    Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

    Self-motivated and adaptable mindset

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