Global Head, Patient-Driven Outcomes Solutions
Scorpion Therapeutics, Cambridge, Massachusetts, us, 02140
Role Summary
Global Head, Patient-Driven Outcomes Solutions (PDOS) leads a global team to ensure patient priorities are integrated into the evidence generation of clinical programs, delivering differentiated value to patients, healthcare professionals, regulators, and payers. The role collaborates cross-functionally to drive industry-leading innovation in clinical outcomes capabilities using digital health, AI, and real-world data to transform evidence generation, regulatory strategy and value assessment. Location: Cambridge, MA; Morristown, NJ; or Paris, France. Responsibilities
Strategic Leadership: as a member of the Patient Informed Development & Health Value Translation Leadership team, manage and direct the clinical outcomes assessment scientists and digital biomarker/ePRO teams; define global PDOS strategy across therapeutic areas to deliver best-in-class products with recognized value by patients, HCPs, regulators and payers; position PDOS to link early evidence generation to labeling, regulatory and payer decisions; advise R&D leadership on integrating patient perspectives into development evidence using leading modeling and measurement capabilities; build and lead cross-functional teams of PROs, digital health, AI and patient engagement; foster collaboration and continuous learning. Digital, RWE, AI & Data-Based Medicine: establish a best-in-class COA roadmap leveraging digital capabilities to differentiate and de-risk the pipeline; collaborate to lead next-generation capabilities in digital health technologies, AI/ML modeling and simulation for endpoints, patient stratification, and personalized evidence generation; drive COA-related real-world evidence strategy to increase asset differentiation and support value demonstration; advance conceptual modeling and dossier authoring using digital capabilities. Clinical Development, Regulatory and Payer Excellence: identify and implement next-generation capabilities to advance COA value and evidence generation; ensure patient-driven outcomes strategies are embedded in clinical trial design and aligned with regulatory and HTA expectations; integrate digital COA solutions (e.g., ePRO/DBM) into trials with ease of implementation and patient/trial-site experience; lead the development of evidence packages including COAs, digital endpoints, and RWE for global regulatory and payer submissions; partner with Regulatory Affairs to engage with health authorities on qualification of novel digital measures and expand PED-related evidence generation; collaborate with the Head of Market Access to link outcomes to value in key markets. External Engagement: represent Sanofi in global consortia and regulatory workshops focused on digital health and patient-centered outcomes; build strategic partnerships with technology providers, academic institutions, and patient advocacy organizations to deliver best-in-class outcomes solutions; lead Sanofi’s thought leadership in patient-driven outcomes and evolve integrated patient engagement across the company. Qualifications
Education: Advanced degree in health economics, qualitative and quantitative COA research. Experience: 15+ years in the pharmaceutical, biotech, or healthcare industry; 10+ years in a senior leadership role focused on patient-driven outcomes, digital health, and exposure to real-world evidence; significant demonstrated experience in digital innovation related to COA; proven track record of successful submissions incorporating patient-centered outcomes; recognized within industry as a thought leader. Skills: Deep understanding of clinical development, regulatory science, and clinical outcomes and health economics; expertise in digital health technologies and AI/ML applications; strong leadership, communication, and cross-functional collaboration; experience working in a global, matrixed environment.
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Global Head, Patient-Driven Outcomes Solutions (PDOS) leads a global team to ensure patient priorities are integrated into the evidence generation of clinical programs, delivering differentiated value to patients, healthcare professionals, regulators, and payers. The role collaborates cross-functionally to drive industry-leading innovation in clinical outcomes capabilities using digital health, AI, and real-world data to transform evidence generation, regulatory strategy and value assessment. Location: Cambridge, MA; Morristown, NJ; or Paris, France. Responsibilities
Strategic Leadership: as a member of the Patient Informed Development & Health Value Translation Leadership team, manage and direct the clinical outcomes assessment scientists and digital biomarker/ePRO teams; define global PDOS strategy across therapeutic areas to deliver best-in-class products with recognized value by patients, HCPs, regulators and payers; position PDOS to link early evidence generation to labeling, regulatory and payer decisions; advise R&D leadership on integrating patient perspectives into development evidence using leading modeling and measurement capabilities; build and lead cross-functional teams of PROs, digital health, AI and patient engagement; foster collaboration and continuous learning. Digital, RWE, AI & Data-Based Medicine: establish a best-in-class COA roadmap leveraging digital capabilities to differentiate and de-risk the pipeline; collaborate to lead next-generation capabilities in digital health technologies, AI/ML modeling and simulation for endpoints, patient stratification, and personalized evidence generation; drive COA-related real-world evidence strategy to increase asset differentiation and support value demonstration; advance conceptual modeling and dossier authoring using digital capabilities. Clinical Development, Regulatory and Payer Excellence: identify and implement next-generation capabilities to advance COA value and evidence generation; ensure patient-driven outcomes strategies are embedded in clinical trial design and aligned with regulatory and HTA expectations; integrate digital COA solutions (e.g., ePRO/DBM) into trials with ease of implementation and patient/trial-site experience; lead the development of evidence packages including COAs, digital endpoints, and RWE for global regulatory and payer submissions; partner with Regulatory Affairs to engage with health authorities on qualification of novel digital measures and expand PED-related evidence generation; collaborate with the Head of Market Access to link outcomes to value in key markets. External Engagement: represent Sanofi in global consortia and regulatory workshops focused on digital health and patient-centered outcomes; build strategic partnerships with technology providers, academic institutions, and patient advocacy organizations to deliver best-in-class outcomes solutions; lead Sanofi’s thought leadership in patient-driven outcomes and evolve integrated patient engagement across the company. Qualifications
Education: Advanced degree in health economics, qualitative and quantitative COA research. Experience: 15+ years in the pharmaceutical, biotech, or healthcare industry; 10+ years in a senior leadership role focused on patient-driven outcomes, digital health, and exposure to real-world evidence; significant demonstrated experience in digital innovation related to COA; proven track record of successful submissions incorporating patient-centered outcomes; recognized within industry as a thought leader. Skills: Deep understanding of clinical development, regulatory science, and clinical outcomes and health economics; expertise in digital health technologies and AI/ML applications; strong leadership, communication, and cross-functional collaboration; experience working in a global, matrixed environment.
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