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  • Director Medical Safety Officer Oncology - Titusville - Johnson & Johnson

    Johnson & Johnson
    Johnson & Johnson Titusville

    1 month ago

    Default job background
    Description

    Job Title: Director, Medical Safety Officer, Oncology (Solid Tumor)

    Location:

    • Titusville, NJ; Raritan, NJ; or Horsham, PA
    • Allschwil, Switzerland
    • Beerse, Belgium
    • United Kingdom or Ireland

    Job Summary:

    The Pharmaceuticals Medical Safety Officer has accountability for assessing the medical safety of assigned Johnson & Johnson products and will strategically lead cross-functional matrix teams responsible for product safety and benefit-risk oversight, representing Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk.

    Key Responsibilities:

    1. Strategically lead the Safety Management Teams (SMT) for assigned products, including safety surveillance (signal detection) and risk management activities (Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)).
    2. Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.
    3. Anticipate safety concerns and influence other relevant functions, including Clinical and Medical Affairs teams, to minimize/mitigate patient impact by participating in the design of clinical protocols.
    4. Be an active partner and core contributor of safety input to key regulatory or clinical documents.

    Qualifications:

    1. Physician (MD or equivalent) with a minimum of 2 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research, Medical Affairs).
    2. Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience.
    3. Board Certification (if US) preferred; Medical specialization preferred.
    4. Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred.
    5. Ability to influence, negotiate and communicate with both internal and external stakeholders.
    6. Experience with Health Authority presentations is preferred.

    Required Technical Knowledge and Skills:

    1. Ability to effectively and strategically lead global cross-functional teams.
    2. Connect, collaborate and build consensus across relevant functions.
    3. Ability to think strategically, has a global mindset, and a big picture orientation.
    4. Ability to critically evaluate safety data from multiple sources and present the findings clearly.
    5. Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally.
    6. Able to plan work to meet deadlines and effectively handle multiple priorities.
    7. Excellent verbal and written communication skills, including formal presentation skills.
    8. Fluent in written and spoken English.
    9. Proficiency in Word and PowerPoint is desired.

    Compensation:

    The anticipated base pay range for this position is $194,000 to $334,650.


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