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Director, Medical Outcomes Research

External
Viatris logoViatris · Remote
Full-timeRemote1w ago
Clinical TrialsElectronic Health RecordsLeadershipStatistical Analysis
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Health insurance

Additional Information

Mylan Inc. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Every day, we rise to the challenge to make a difference and here's how this Director, Medical Outcomes Research role will make an impact: Key responsibilities for this role include: 1. Evidence Generation Integrated Evidence Generation Plan: Lead and execute US and global cross-functional/integrated evidence generation plans to support medical affairs, clinical development, market access and health economics, regulatory affairs, and commercial needs for the innovation portfolio, including Women's Health. Observational Studies: Design and execute retrospective and prospective observational studies-including burden-of-illness, natural history, and incidence/prevalence assessments-to evaluate impact of disease, effectiveness, and safety of products. Comparative Evidence Generation: Lead the design and execution of comparative studies, including Comparative Effectiveness Research (CER) using large-scale real-world databases, Indirect Treatment Comparisons (ITC) leveraging clinical trial data, and the development of External Control Arms (ECA) utilizing integrated real-world and clinical trial data sources. Systematic Literature reviews and Meta-analyses: Lead the strategy and execution of select literature reviews and meta-analyses to inform internal decision-making and support high-quality HTA dossier submissions and regulatory requirements. Patient reported outcomes: Lead the integration of patient voice through quality-of-life instruments into clinical trials and oversee the design of patient surveys and validated instruments for regulatory and HTA submissions. 2. Strategic Leadership and Collaboration Working with internal colleagues and external stakeholders, lead and develop Outcomes Research strategies to support the company's innovation portfolio of products and therapeutics, ensuring incorporation of clinical, humanistic and economic endpoints into clinical trial designs and development plans across all phases of development. Collaborate with cross-functional teams (e.g., clinical development, medical affairs, market access, regulatory affairs, and commercial teams) to ensure alignment of Outcomes Research initiatives with the company's strategic goals. Build and maintain relationships with key stakeholders in academic, healthcare and payer domains to support Outcomes Research initiatives. Engage with industry associations, policymakers, and thought leaders to advocate for the importance of real-world evidence and Outcomes Research in shaping healthcare decisions and adoption of medications. 3 . Communication Communicate complex scientific and technical findings clearly and effectively to senior leadership (C-suite, VP-level), ensuring they are aligned with business objectives and can drive strategic decisions. Communicate Outcomes Research strategies and findings through high-impact peer-reviewed publications, scientific congresses, and advisory meetings. 4. Operational Excellence Develop and/or review observational research, outcomes research protocols, statistical analysis plans (SAPs), and reports. Closely work with a team of Outcomes Research scientists and researchers, ensuring high standards of research quality, efficiency, and productivity. Ensure adherence to regulatory requirements and ethical standards for Outcomes Research studies, including data privacy and patient consent. Monitor budget and resource allocation for Outcomes Research initiatives, ensuring effective use of resources and alignment with organizational priorities. 5. Data Strategy and Methodology Manage the selection and use of real-world data sources (e.g., electronic health records, claims data, registries, patient-reported outcomes) to support evidence generation. Develop and apply cutting-edge methodologies in statistical analysis, epidemiology, and health economics to generate robust evidence. Ensure data quality and integrity, including the appropriate validation, cleaning, and analysis of real-world data. The minimum qualifications for this role are: Master's degree required. Advanced degree (PhD, MD,) in epidemiology, public health, biostatistics, or a related field strongly preferred. Advanced degree (PhD, MD,) in epidemiology, public health, biostatistics, or a related field strongly preferred. Master's degree required. Research Expertise: Depth and breadth of experience in Ou


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