Role Summary
Director, Outcomes Research. Lead and execute global, cross-functional evidence generation plans to support medical affairs, clinical development, market access, health economics, regulatory affairs, and commercial needs for the innovation portfolio. Build and lead strategies that integrate clinical, humanistic, and economic endpoints into development plans and trials, while collaborating with cross-functional teams to align with strategic goals. Communicate complex scientific findings to senior leadership and external audiences, ensuring regulatory and ethical standards are met. Responsibilities
Evidence Generation Integrated Evidence Generation Plan: 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 the innovation portfolio. 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. Strategic Leadership and Collaboration 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. 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. 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. 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. Qualifications
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 Outcomes Research (e.g., 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. Skills
Experience managing large and global datasets, conducting complex data analyses, and extracting meaningful insights. Ability to develop and execute strategic plans aligned with business objectives. Excellent written and verbal communication skills, including presenting complex information to diverse audiences. Collaborative mindset with cross-functional teams (medical affairs, clinical development, commercial, regulatory). Strong understanding of the pharmaceutical industry, including drug development, registration, and market access. Technical expertise in study protocol development, methods/algorithms, statistical and data analysis plans, and publications. Record of peer-reviewed real-world evidence studies, Outcomes Research and/or epidemiology publications. Education
Advanced degree (PhD, MD) in epidemiology, public health, biostatistics, or related field strongly preferred. Master’s degree required. Additional Requirements
Remote position that typically involves sitting at a desk or table; occasional standing or walking. Periodic travel, up to 25% time.
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Director, Outcomes Research. Lead and execute global, cross-functional evidence generation plans to support medical affairs, clinical development, market access, health economics, regulatory affairs, and commercial needs for the innovation portfolio. Build and lead strategies that integrate clinical, humanistic, and economic endpoints into development plans and trials, while collaborating with cross-functional teams to align with strategic goals. Communicate complex scientific findings to senior leadership and external audiences, ensuring regulatory and ethical standards are met. Responsibilities
Evidence Generation Integrated Evidence Generation Plan: 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 the innovation portfolio. 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. Strategic Leadership and Collaboration 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. 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. 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. 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. Qualifications
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 Outcomes Research (e.g., 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. Skills
Experience managing large and global datasets, conducting complex data analyses, and extracting meaningful insights. Ability to develop and execute strategic plans aligned with business objectives. Excellent written and verbal communication skills, including presenting complex information to diverse audiences. Collaborative mindset with cross-functional teams (medical affairs, clinical development, commercial, regulatory). Strong understanding of the pharmaceutical industry, including drug development, registration, and market access. Technical expertise in study protocol development, methods/algorithms, statistical and data analysis plans, and publications. Record of peer-reviewed real-world evidence studies, Outcomes Research and/or epidemiology publications. Education
Advanced degree (PhD, MD) in epidemiology, public health, biostatistics, or related field strongly preferred. Master’s degree required. Additional Requirements
Remote position that typically involves sitting at a desk or table; occasional standing or walking. Periodic travel, up to 25% time.
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