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    Sr Medical Director/Medical Director - New Jersey, United States - Meet

    Meet
    Meet New Jersey, United States

    2 weeks ago

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    Description

    Job Description: Senior Medical Director/Medical Director, Medical Affairs

    Overview: Be part of our client's team as a Senior Medical Director/Medical Director, Medical Affairs, where you'll lead with medical, scientific, strategic, and operational expertise. Your role involves tasks such as producing clinical and scientific data, enhancing therapeutic outcomes, ensuring safety and value, working with healthcare professionals, and engaging in medical education and scientific communication. You will collaborate closely with diverse teams to drive medical affairs initiatives that advocate for the safe and appropriate use of our clients' medications. Additionally, you will champion healthcare professionals (HCP) and patients, providing evidence-based medical insights for brand strategies, marketing, and market access efforts.

    Key Responsibilities:

    • Medical Affairs Leadership: Initiate and steer medical affairs activities, data generation, and sharing to bolster the overall medical and scientific strategy.
    • Clinical Study Oversight: Lead or assist in the planning, analysis, interpretation, and communication of scientific content in study protocols, Investigator Brochures, Clinical Study Reports, and regulatory submissions.
    • Clinical Trials Management: Supervise clinical trials, ensuring resolution of safety issues, interpretation of statistical analysis, selection of Principal Investigators, and compliance with regulations.
    • Safety and Risk Management: Develop and implement safety and risk management plans for clinical trials, analyze and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
    • Study Integrity and Enrollment: Monitor study integrity, interpret and convey safety and efficacy data, and facilitate study enrollment and timelines.
    • Marketing and Education: Create scientifically precise marketing materials, medical education initiatives, advisories, and symposia.
    • Research and Development Support: Aid in the scientific evaluation, development, approval, execution, and communication of medically backed research sponsored or supported by medical affairs.
    • Cross-Functional Collaboration: Align scientific and medical activities with internal stakeholders, acting as the scientific point of contact for regulatory conversations.
    • Education and Knowledge Sharing: Offer scientific and medical education to investigators, clinical monitors, project team members, and healthcare providers, staying updated on therapeutic advancements and medical breakthroughs.
    • Compliance and Budget Management: Ensure adherence to regulatory mandates, manage financial allocations, and stick to timelines for scientific undertakings.

    Qualifications:

    • Medical Degree: Medical Doctorate (M.D.), D.O., or equivalent from non-US institutions.
    • Experience: Minimum of 2 years in medical affairs, clinical trials, or pharmaceutical industry or academic clinical practice, with a preference for 3+ years.
    • Expertise: Proficiency in clinical trial methodologies, data analysis, regulatory obligations, development strategies, and protocol formulation.
    • Leadership: Demonstrated leadership acumen in a cross-functional global team setting.
    • Communication Skills: Exceptional verbal and written communication skills in English.
    • Technical Proficiency: Proficient in Microsoft Office applications.
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