• Executive Director Medical Safety, Global Patient Safety

    Job Locations US-IL-Bannockburn
    Posted Date 6 months ago(6/14/2018 3:44 PM)
    Job ID
    2018-1303
    # of Openings
    1
    Category
    Global Patient Safety
  • 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.

     

    The Sr. Director, Medical Safety, Global Patient Safety, reports to the Head of Global Patient Safety (GPS).  The Director is a senior drug safety medical expert responsible for safety surveillance, risk management, and risk communication for assigned products as well as medical assessment of individual adverse event reports, generation and review of aggregate reports and management of safety signals. The Director is the leader of safety review team for assigned products and responsible for the assessment of benefit-risk profiles and related actions across product life cycle. He/she will provide medical safety review input into all critical documents for products in clinical development and post-marketing. The Director will work closely with the Head of GPS and QPPV to develop the strategic roadmap for managing the safety of assigned products.

     

    This individual should be a self-starter with excellent leadership and management capabilities who is seeking to be part of an innovative and fast-paced team to support the company’s drug development activities.

    Responsibilities

    • Responsible for review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post-marketing for assigned AveXis products.
    • Responsible for conducting Signal detection activities, monitoring, evaluation, interpretation, management and communication of safety information.
    • Chair the cross-functional Safety Management Team for assigned products and responsible for the assessment of benefit-risk across product lifecycle.
    • Perform aggregate safety data tabulation and listing compilation
    • Collaborate with clinical team, vendor and CRO safety physicians, medical monitors, toxicology group, and other functional groups in identification, analysis, and reporting of possible safety signals.
    • Contribute to development & maintenance of product safety profile. Provide medical safety input into all critical documents (e.g. protocols and amendments, IBs, CSRs, submission dossiers, INDs, BLAs etc.)
    • Track events of special interest and assist in development & maintenance of standardized queries for events of special interest
    • Develop strategy for the analysis in support of responses to regulatory, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues
    • Draft regulatory inquiry responses and provide oversight on key content of risk management documents (RMPs, REMs).
    • Author and review to key regulatory or clinical documents (i.e. clinical study reports, investigator brochures, integrated summaries of safety, DSUR).
    • Participate in regulatory meetings, interactions and submission activities (ISS, 120-day safety update) as necessary.
    • Lead internal safety management team meetings as well as joint safety meetings with licensing partners.
    • Communicate effectively on product safety issues and proposes solutions to senior management and the QPPV.
    • Develop and maintain strong relationships with key stakeholders including clinical development, medical affairs, regulatory affairs. Licensing and marketing organization to better understand and fully support business objective.

    Qualifications

    • M.D. is required with 3-5 years of clinical experience
    • Clinical experience in relevant areas (e.g. infectious disease, immunology, neurology, pediatrics) are desirable.
    • Min 5-10 years' experience in the pharmaceutical industry, predominately in Pharmacovigilance, having worked on both development and marketed products.
    • Clinical development and/or drug safety experience with biologics, gene therapy products desirable.
    • Experience with successful BLA submission, regulatory interactions and approvals, a plus.
    • Collaborate effectively with the clinical study team, cross-functional team members, and external partners.
    • Credible knowledge of global regulations governing Pharmacovigilance for products in clinical development and post-marketing.
    • Strong organizational, planning, prioritizing and problem-solving skills
    • Effective multi-tasking skills, applied in different and complex assignments and ability to work effectively under pressure and under strict timelines
    • Ability to work both independently and collaboratively and use own initiative
    • Ability to communicate effectively both locally and globally, internally and externally
    • Proficient MS Office skills
    • Personality and attitude
    • Approachable, flexible and self-motivated
    • Open to changes, suggestions and innovations, continuously on the look-out for work processes' improvements
    • Tolerance for ambiguity and ability to adapt quickly to a changing business environment
    • Highly resilient, tenacious and resourceful
    • Occasional travel (up to 40%) for conferences, meetings and professional development activities
    • High attention to details

     

     Non-Essential Functions: 

    • Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices.
    • Maintains a positive and professional demeanor toward all customers and coworkers.
    • Adheres to all policies and procedures of AveXis.
    • Performs other duties as assigned.

    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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