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  • Lupus Clinical Lead

    JNJCSpring House, PA

    Job #112865674

  • Janssen R&D, a member of Johnson & Johnsons Family of companies, is
    recruiting for a Lupus Clinical Lead, for the Estrela venture within the
    Janssen Incubator, located in Spring House, PA.

    Estrela is an entrepreneurial, scientifically-driven, Lupus-focused venture
    team within the newly established Janssen Incubator of Janssen R&D. We
    receive milestone-based funding and are leveraging external and Janssen R&D
    functional support to progress bio-therapeutic assets to clinical
    proof-of-mechanism in Lupus. We are committed to partnering with the
    external health care community, delivering superior biomedicines, and
    discovering patient-centric solutions for Lupus.

    Thriving on a diverse company culture, celebrating the uniqueness of our
    employees and committed to inclusion. Proud to be an equal opportunity
    employer.

    The Lupus Clinical Lead will partner closely with Estrela scientists to
    drive the strategic design and execution of proof-of-mechanism Lupus
    clinical studies to deliver on our venture goal and advance the Janssen R&D
    Lupus portfolio. They will oversee Phase 0/1 study conduct including:
    strategic collaborations with Lupus key opinion leaders; identification of
    clinical sites and CROs that will participate in trials; review budgets and
    timelines to ensure that trials are competitive; partner with internal or
    external staff responsible for study execution, analysis and reporting;
    review and interpret clinical trial data to enable timely internal
    decision-making; external communication with investigators and regulatory
    agencies; and oversee the preparation and assure the accuracy of INDs and
    clinical study reports. The Lupus Clinical Lead will ensure adherence to
    GCP and to all relevant internal and external guidances. If MD or MD/PhD,
    this position will be responsible for medical monitoring and safety aspects
    of Lupus clinical trials. If PhD, this position will partner closely with
    assigned medical monitor to ensure safety aspects are fully compliant. The
    Lupus Clinical Lead will prepare and/or direct the preparation and review
    of protocols, clinical study reports, clinical pharmacology and
    translational medicine sections of early development plans, IBs, INDs,
    abstracts, manuscripts, and technical reports, as needed. In addition, the
    Lupus Clinical Lead will be responsible for presentation of results and
    updates at internal meetings.

    A Ph.D with post-doctoral experience and 12 years of business experience,
    or an M.D./Ph.D or M.D. with a minimum of 3 years industry experience is
    required. Previous Lupus clinical research experience is required and
    observational or interventional Lupus clinical trial experience is
    preferred. Other required competencies include: fluency in written and
    spoken English; working knowledge of the use of Microsoft suite of software
    products including Excel, Word, and Power Point; the ability to advise,
    persuade and negotiate with colleagues in a supportive and encouraging
    fashion; strong presentation and project management skills; being able to
    work in a cross-functional team environment; and willingness and ability to
    travel up to 10% f the time. Good organizational skills with the ability to
    multi-task and prioritize assignments and a record of peer reviewed
    publication and experience in scientific presentations is preferred.

    BE VITAL in your career, Be seen for the talent you bring to your work.
    Explore opportunities within the Johnson & Johnson Family of Companies.

    J2W: LI

    Updated

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