• Director, Clinical Operations

    Job Locations US-IL-Bannockburn
    Posted Date 1 week ago(8/7/2018 2:33 PM)
    Job ID
    2018-1288
    # of Openings
    1
    Category
    Medical Affairs
  • 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., a Novartis Company, 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.

     

    This position will be responsible for overseeing the clinical study planning and timelines and in some cases budgets for multiple clinical development programs. These responsibilities include, but are not limited to, vendor identification and selection, review of study related materials, management of vendor relations, management of study team personnel, identification of project risks and contingency planning. This position will also participate in growth of the Clinical Operations Department and will build processes and infrastructure required according to best industry standards.  Must be able to work at a fast pace and manage multiple complex projects.

     

    Responsibilities

    • Lead in-house clinical operations.
    • Identify and evaluate potential clinical partners which may include investigators and vendors necessary to execute the clinical program.
    • Provide strategic input into the development of clinical trial protocols to ensure clinical designs are implementable to efficiently achieve the objectives.
    • Provide strategic input into the collection and analysis of clinical trial data.
    • Establish aggressive but credible timelines and budget for delivery of development program.
    • Oversee, coach and develop staff responsible for delivery of clinical trials.
    • Develop contingency/risk management plans for projects with a focus on ensuring studies deliver according to principles of GCP.
    • Develop and review Clinical Development processes, systems and initiatives.

    Qualifications

    • Degree in Life Sciences preferred; bachelors required, masters preferred.
    • Five or more years of progressive clinical operations experience.
    • Excellent regulatory knowledge including, but not limited to, Good Clinical Practices (GCPs), ethics requirements for protection of human subjects, set-up and maintenance of Trial Master Files.
    • Experience with CTMS and data systems (i.e., IMPACT, Medidata RAVE, GRANTS MGR).
    • Demonstrated effective planning and project management skills.
    • Excellent understanding of multi-cultural / multi-national environment.
    • Proven track record of conducting, managing phase II/III trails.
    • Demonstrated effective planning and project management skills.
    • Excellent analytical, written, and verbal communication skills as well as presentation skills with working knowledge of Microsoft Office applications including Word, Excel Power Point, Visio, MS Project.

    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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