Jazz Pharmaceuticals

  • Senior Director, Clinical Development (CNS)

    Job Locations US-CA-Palo Alto | US-PA-Philadelphia
    Posted Date 2 months ago(9/12/2018 10:25 AM)
    Job ID
    2018-3799
    # of Openings
    1
    Category
    Research & Development
  • Overview

    Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


    Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


    We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

    Position Profile

    This opportunity is available in Palo Alto, CA and Philadelphia, PA,

    Brief Description:

    The Senior Director, Clinical Development, will join a rapidly-growing team in the Sleep & CNS Therapeutic Area. Responsibilities include clinical leadership of global clinical development plans and protocols to support new and existing programs; medical monitoring, scientific oversight, interpretation and dissemination of clinical trial data; support of regulatory interactions; and representing clinical development in cross-functional matrix teams within Jazz

    Essential Functions

    • Provide leadership and medical input for clinical programs, clinical protocols in development, ongoing clinical trials, clinical study reports and regulatory documents
    • Collaborate closely with team members in clinical development, operations, biostatistics, regulatory, pharmacovigilance, early development, and other functions to facilitate the execution of quality clinical trials and programs
    • Serve as medical monitor on trials for products under development in Sleep Medicine & CNS and make recommendations based on safety findings to team, as needed; collaborate closely with  CRO and study investigators on clinical trial eligibility and subject and patient safety issues
    • Review, interpret, and approve safety and efficacy data in clinical study reports, regulatory documents and submissions (e.g., IND and NDA)
    • Provide strategic input on new product concepts, long-range strategic plans and life-cycle management opportunities
    • Engage external experts to obtain scientific input and to integrate current clinical  practice and guidelines into global clinical development plans, including  relevant industry developments
    • Serve as clinical resource for issues raised by a range of collaborators, investigators, consultants and corporate/investor contacts

    Required Knowledge, Skills, and Abilities

    • 5+ years academic and/or pharmaceutical industry experience
    • Demonstrated expertise in CNS global clinical development (experience in cognitive-behavioral disorders such as ADHD preferred)
    • Excellent oral and written communication skills
    • Knowledge of GCP, Drug Safety, MedDRA safety coding and Pharmacovigilance processes
    • Values-based leadership evident in personal interactions at all levels of the company
    • Proactive and effective work style, with creative problem-solving skills
    • Ability to travel; over short periods of time, travel can be up to 25-50%.

    Required/Preferred Education and Licenses

    • MD or DO is required
    • Board Certification in Neurology, Psychiatry, or equivalent CNS training is preferred
    • US licensure and/or clinical practice experience is preferred

    Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

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