Director, Outcomes Research

Viatris is a healthcare company that aims to empower people worldwide to live healthier at every stage of life. The Director of Outcomes Research will lead and execute evidence generation strategies to support medical affairs and clinical development, collaborating with cross-functional teams to ensure alignment with the company’s strategic goals.

Responsibilities:

• Lead and execute global, cross-functional/integrated evidence generation plans to support medical affairs, clinical development, market access and health economics, regulatory affairs, and commercial needs for innovation portfolio
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Requirements:

• Master's degree required
• Depth and breadth of experience in Outcomes Research (such as, but not limited to, retrospective or prospective observational studies, patient-reported outcomes/health-related quality of life assessment, clinical-economic modeling and analysis, meta-analysis) is required
• 5 years' biopharmaceutical industry experience in evidence generation and Outcomes Research methodologies, with a track record of successful project delivery for innovative products in development
• Proficiency in speaking, comprehending, reading and writing English is required
• Advanced degree (PhD, MD,) in epidemiology, public health, biostatistics, or a related field strongly preferred
• Experience managing large and global datasets, conducting complex data analyses, and extracting meaningful insights
• Demonstrated ability to develop and execute strategic plans aligned with business objectives
• Excellent written and verbal communication skills, including the ability to present complex information to diverse audiences
• Proven ability to collaborate effectively with cross-functional teams, including medical affairs, clinical development, commercial, and regulatory
• A strong understanding of the pharmaceutical industry, including drug development, registration and commercialization including market access
• Technical expertise including study protocol development, methods/algorithms, statistical and data analysis plan, and insights for publications
• Record of high-quality, peer-reviewed real world evidence studies, Outcomes Research and/or epidemiology research publications