• Director, Toxicologist

    Job Locations US-CA-San Diego
    Posted Date 2 months ago(2/9/2018 9:38 AM)
    Job ID
    2018-1124
    # of Openings
    1
    Category
    R & D
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical setting for patients and families devastated by rare neurological genetic diseases?  AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101.  We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

     

    AveXis, Inc. is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

     

    AveXis is seeking a Director, Toxicologist.  This individual will serve as a primary source of scientific expertise for the design, analysis, reporting and presentation of data from clinical studies conducted to support research and development.

    Responsibilities

    • Provide strategic direction for the design, interpretation, and reporting of regulatory toxicity studies
    • Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of potential gene therapy candidates through close interactions with discovery toxicologists, and affiliated nonclinical and clinical development functions as necessary
    • Coordinate toxicological/nonclinical safety evaluations of development candidates locally and internationally with external contract laboratories, consultants, and development partners
    • Responsible for lead authorship of pertinent sections of internal and external regulatory documents (BLAs, INDs, Expert Reports, etc.)
    • Address and resolve toxicological issues arising in drug development programs, and adequately assess the relevance of any toxicological findings to human safety.
    • Build strong scientific collaborations with external groups within both the academic and industry fields
    • Collaborate on design of investigative toxicity studies in support of development compounds
    • Negotiates toxicology and testing requirements and positions within Trade Associations, governmental authorities and external experts.
    • Recognized as an expert within the organization and industry.
    • Interacts with federal and global regulatory agencies on toxicology matters relative to product registration and new regulations.
    • Negotiates testing requirements with Global Regulatory Authorities.

    Qualifications

    • Ph.D. in Toxicology or relevant field; DABT Board certification preferred.
    • 10+ years of experience in the Pharmaceutical/Biotech Industry with a proven track record of conducting drug safety assessment studies, demonstrates ability to manage multiple projects and make sound scientific interpretations and risk assessments and decisions.
    • Expert knowledge of toxicology is required
    • Expertise in a toxicology specialty area (gene therapy) preferred
    • In depth understanding and working knowledge of regulatory toxicology and US and international regulatory guidelines
    • Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities
    • Strong interpersonal skills with an ability to develop solid, long-term relationships and to work effectively in a team setting/matrix-type organization
    • Excellent oral and written communication capabilities

     

    The level of this position will be based on the final candidate’s qualifications.

     

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

     

    AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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