Senior Director, Medical Evidence and Outcomes Research
PharmaBiotechClinical ResearchRegulatory AffairsQuality Assuranceheorbiostatisticscdmcroraveinform
Job description
Job title: Senior Director, Medical Evidence and Outcomes Research Location: Remote, US (Cambridge, MA / Morristown, NJ) About the job Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you’ll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. Job Summary: The Medical Evidence and Outcomes Research Lead will serve as a Center of Excellence for managing local evidence generation partnerships across the North America Specialty Care portfolio. Working closely with key stakeholders across Global and US medical units, clinical development, RWE, HEVA, Access Strategy, and commercial functions, this role will identify and prioritize local evidence needs, ensure strategic alignment between local and global evidence generation plans, and serve as a resource to field medical teams and medical units as a subject matter consultant on RWD/RWE related needs/projects to drive consistent, high-quality implementation of evidence generation initiatives across the Specialty Care portfolio. This role will also serve as a key scientific liaison to external stakeholders, identifying and developing credible partnerships with payer/population healthcare decision-makers (HCDMs), health outcomes research organizations, and academic collaborators that aim to inform healthcare decision making, improving patient access and outcomes. This position plays a critical role in bridging local and global evidence generation priorities, facilitating cross-functional collaboration, and advancing the organization's ability to generate, communicate, and leverage meaningful real-world evidence and outcomes research collaborations that contribute to clinical value proposition and improve gaps in care. The Medical Evidence and Outcomes Research Lead will report to the Head, Medical Value and Outcomes as a member of the North America Specialty Care Medical organization. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities: 1. Evidence Generation Contribute to the design and development of integrated evidence generation plans, including the identification and prioritization of local evidence needs important to HCDMs that are aligned with strategic imperatives Serve as an internal expert for evidence generation methodologies, vendors, and data assets, providing strategic input on the implementation of local evidence generation plans and projects Establish clear, consistent processes for local evidence generation planning and implementation consistent with global governance to ensure quality, compliance, and alignment across key internal stakeholders Develop and implement processes to appropriately monitor contributions, performance, and impact of local evidence generation efforts across NA medical teams Serve as a source of expertise for developing RWE studies to support US labeling requirements Align priorities and resources to support local capability development in evidence generation Facilitate internal networking and partnership to optimize awareness and utilization of available internal resources Ensure adherence to all appropriate compliance and governance processes As a RWD methodological expert, support medical care gap development as needed 2. External RWE & Health Outcomes Research Collaborations Identify, develop, and maintain credible scientific partnerships with key external stakeholders, including payer/population healthcare decision-makers, health outcomes research centers/organizations, and academic collaborators Facilitate the development and placement of appropriate evidence-based disease management, health outcomes, and population health management studies aligned with medical brand strategy and in collaboration with relevant internal stakeholders, consistent with all applicable policies and procedures Serve as a medical expert to guide development of quality improvement initiatives and lead the quality improvement review process Lead clinical insight generation efforts directed at US HCDMs to identify evidence gaps and gain input on product clinical development plans for pipeline and marketed products Lead/coordinate the submission of RWE/outcomes research project data for presentation at congresses and/or scientific publications Provide strategic medical/clinical evidence input for value-based contracting arrangements Provide input and recommendations on evidence development and delivery of field tools, resources, materials, and training designed to convey medical and payer/population HCDM value 3. Cross-Functional Collaboration & Strategic Alignment Work closely with NA Medical leadership to provide strategic input into evidence generation priorities, planning, and design Ensure strong collaboration and partnership with global and US medical units, RWE, clinical development, HEVA, brand, and other relevant stakeholders across the Specialty Care portfolio Facilitate opportunities to expand country medical input into evidence generation and life-cycle management (LCM) planning processes and forums Establish/manage processes and expectations to facilitate strong internal cross-functional collaboration centered around local evidence generation partnerships Work cross-functionally with medical, clinical development, HEVA, Access Strategy, RWE, to ensure insights inform strategic and tactical planning efforts Provide input and recommendations related to evidence needs, product value-proposition/medical communications, and educational opportunities Contribute to publication plans and strategic/tactical planning efforts Support the strategic assessment of and provide country medical input on potential data resources and data licensing partnerships About You Knowledge, Skills, and Competencies: Deep understanding of the US healthcare landscape, public health and industry trends, and regulatory and payer environment, with the ability to accurately identify key issues and develop evidence generation strategies and plans High degree of knowledge of HEOR disciplines, evidence generation methodologies, and a solid understanding of biostatistics and evidence-based medicine (research methodology, clinical protocols, clinical reports) Demonstrated ability to develop and implement a roadmap to take the organization from present to future state Proven ability to manage complex environments, motivate and guide cross-functional teams with multiple skill levels through clear expectations and appropriate management toward successful outcomes Excellent interpersonal, communication, and presentation skills Advanced strategic thinking and business acumen, leveragin
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