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    Real World Evidence Clinical Lead - Cambridge, United States - Sarepta Therapeutics Inc.

    Sarepta Therapeutics Inc.
    Sarepta Therapeutics Inc. Cambridge, United States

    1 week ago

    Default job background
    Freelance
    Description

    The Real World Evidence (RWE) lead provides clinical leadership for evidence generation activities, supporting the integration of RWE into Sarepta key strategic initiatives.

    The role functions in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Medical Affairs, Research and Legal.


    Primary Responsibilities Include:

    • Provide clinical leadership and contributes to integration of clinical development process & post-marketing activities and other RWE and HEOR activities
    • Contribute to the development of real world evidence strategies for post marketing programs, and health economics and patient outcomes research initiatives
    • Contribute to the design and conduct of pharmacoepidemiology studies ( ie studies assessing comparative safety and effectiveness, registries, cohort, surveys, case-control or drug utilization studies).
    • Provide medical monitoring of observational studies
    • Develop effective relationships with key opinion leaders and decision makers both internally and externally
    • Contribute to publication development and other external scientific exchange
    • Leads assessment, interpretation & communication of relevant scientific literature; maintains awareness of internal & external data resources & identifies appropriate studies for addressing questions of interest
    • Collaborate with other functional groups (PV, Medical Affairs, Commercial, Regulatory Affairs)
    • Maintains knowledge & skills on evolving epidemiological, health economics methods, tools & data sources.
    • Recognized as an expert and thought leader
    • Communicate with external thought leaders

    Desired Education and Skills:

    • MD with additional Epidemiology/Pharmacoepidemiology/Health Economics graduate education and experience in the pharmaceutical industry.
    • Proven experience in epidemiology, health economics or real world evidence including post including a minimum of 10 years' pharmaceutical industry experience
    • Experience with medical monitoring and leading post marketing studies
    • Proven RWE experience with claims, EHRs, and prospective data
    • Knowledge and experience with PROs and PRO data capture
    • Experience contributing the design and implementation of natural history studies and registries in the pharmaceutical industry is required; experience with rare disease is a plus.
    • Strong statistics experience and knowledge
    • Ability to effectively work in a cross-functional team environment.
    • Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors.
    • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
    • Receives minimal supervision
    • Excellent problem solving skills and on time deliverable success
    #LI-Remote
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