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SR. MEDICAL AFFAIRS DIRECTOR

Company: Johnson & Johnson
Location: Irvine
Posted on: December 7, 2018

Job Description:

Every six seconds someone dies from a stroke. Stroke can be caused either by a clot obstructing the flow of blood to the brain (ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (hemorrhagic stroke). CERENOVUS is committed to changing the trajectory of stroke by providing physicians with innovative technologies to push the boundaries of whats possible in neurovascular intervention. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.

The Senior Medical Director will have global medical affairs responsibility in support of the diagnosis and treatment of vascular disease in the central nervous system to co-develop and deliver global innovation and life cycle business strategy. This role will also establish long term product opportunities, as well as unmet medical needs, and evidence needed for development programs and post market products. The Senior Medical Director will Shape the industry and build strong relationships externally with key customers and stakeholders (Key Opinion Leaders, Surgeons, Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends, understand clinical/medical insights, unmet medical needs and global standards of care to deliver quality products/solutions.

The Senior Medical Director will:

---Work with Medical Business Partner to; R&D, Clinical Affairs, Regulatory Affairs, Quality & Regulatory Compliance, Pre-Clinical, Health Economics & Market Access and Professional Medical Education

--- Ensure the development and execution of product and/or procedural evidence generation and dissemination strategies for company sponsored and investigator initiated research

--- Chair the Clinical Research Committee to ensure medical scientific alignment between Clinical Research and the companys strategic needs

--- Participate in Key Governance Forums, including Global Management Boards, Cross

Functional Leadership Teams, Portfolio Management Teams, Protocol Review

Committee, Safety and Quality Review Boards

--- Engage Key Opinion leaders, Professional Societies, Payers and Providers to

understand trends in care, uncover critical insights

--- Provide support to Franchise Marketing, R&D, Communications, Legal, QA/Risk

Management/Product Safety and Commercial teams by providing medical and scientific insights to drive optimal business strategic direction and tactical business activities

--- Collaborate with evidence generation colleagues from Preclinical Research, Clinical

Research and Evidence-Based Medicine (EBM) teams in the USA and internationally

to develop global strategies for evidence generation for new and existing products in

order to support regulatory approval/clearance, health technology assessment,

customer access and post-marketing support

--- Provide scientific and medical expertise, medical oversight and approval for clinical

trial concept, design, analysis and reporting of clinical research in assigned areas

--- Provide medical oversight for the development of materials to be used by Clinical

Operations for study execution (investigator brochures, training materials, etc.)

--- Oversee MDs (internal MDs or consultants) who perform the role of medical monitor

for company sponsored clinical studies. May perform the role of medical monitor for

certain company sponsored pre-approval clinical studies

--- Provide medical input and expertise in the analysis of study results



  • Work with Regulatory and Clinical partners to prepare report on clinical investigations

    preparation for submission to regulatory agencies and/or for publication, to meet

    evidence requirements

    --- Provide medical insights/expertise to the development teams for the risk assessment

    review for new products and reviews and approves the final risk management report

    for all new products

    --- Account for the medical content of internal product documentation and regulatory

    submissions for new products and for renewals.

    --- Approve Design istory Files, Technique Guides and Clinical Evaluation Reports

    (CERs) as part of the creation of product-specific design dossiers/technical files

    --- Provide expert medical response to unsolicited medical information requestsQualifications


    Qualifications



    • A minimum of a MD/MB/DO or equivalent is required. Additional advanced degrees are preferred

    • Experience and focused training in neurovascular and neuroendovascular disease processes and therapeutics is required

    • A minimum of 7 years relevant experience in post graduate medical education (beyond initial licensure) including: specialty residency, fellowship or subspecialty training, clinical practice, dedicated research, or other related advanced training/experience is required
    • A current license to practice is preferred and Board Certification or an equivalent is strongly preferred

    • Two or more years experience in clinical practice as an attending level physician is strongly preferred

    • Significant experience with clinical research is required

    • Strong leadership skills and demonstrated ability to build successful relationships with internal and external partners globally is preferred
    • Strong communication and negotiation skills to successfully influence and implement policy with key customers and partners is preferred
    • Must be able to collaborate well with multiple partners and work effectively in a matrix environment

    • Previous industry experience leading Medical/Clinical/R&D teams in a regulated, commercial biomedical or medical device business is preferred

    • Membership and leadership roles in specialty Professional Societies is desirable
    • Capability, expertise and success in building teams to meet the needs of a global set of businesses serving different clinical specialties or therapeutic areas will be needed

    • Demonstrated success in medical data generation, interpretation and publication highly preferred

    • Experience in product risk evaluation and mitigation is preferred

    • Must have the ability to travel both domestic and internationally


      Primary Location

      United States-California-Irvine-33 Technology Drive

      Organization

      Depuy Orthopaedics. Inc. (6029)

      Job Function

      Medical Affairs

      Requisition ID

      2184181010

      Keywords: Johnson & Johnson, Irvine , SR. MEDICAL AFFAIRS DIRECTOR, Executive , Irvine, California

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