Global Head, Patient-Driven Outcomes Solutions

Role Summary

As Global Head, Patient-Driven Outcomes Solutions (PDOS), you will lead a global team that ensures patient priorities are deeply integrated into the evidence generation of clinical programs, delivering differentiated value to internal and external stakeholders. You will collaborate cross-functionally to drive industry-leading innovation in clinical outcomes capabilities by leveraging 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
  • Manage and direct the Head of Clinical Outcomes Assessment Scientists and team with dotted line reporting responsibilities for the digital biomarker and ePRO teams in Clinical Sciences & Operations.
  • Define and lead Sanofi’s global strategy for patient-driven outcomes across all therapeutic areas to deliver best in class products with recognized value by patients, HCP, regulators and payers through the democratization of the evidence generated.
  • Position PDOS as part of the patient disease strategy that links early evidence generation to labeling, regulatory and payer decision making.
  • Serve as a key advisor to R&D leadership, and project teams, on integrating patient perspectives into clinical development evidence generation in a manner that reflect industry leading modeling and measurement capabilities.
  • Develop a high performing team of clinical outcomes scientists, expert in digital capabilities and novel frameworks of measurement.
  • Build and lead a high-performing, cross-functional team of experts in PROs, digital health, AI, and patient engagement.
  • Foster a culture of collaboration, inclusion, and continuous learning.
• Digital, RWE, AI & Data-Based Medicine
  • Responsible for establishing a best in class COA roadmap using digital capabilities to differentiate, de-risk and increase value of pipeline.
  • Lead the next generation capabilities in collaboration with Evidence Generation & Decision Sciences, therapeutic areas, eDevelopment and Clinical Sciences & Operations, including:
    • digital health technologies (e.g., wearables, mobile apps, remote sensors) into clinical trials as tools to capture real-time, real-world patient data
    • state-of-the-art modeling and simulation capabilities in pre-clinical to identify novel endpoints using AI/ML and advanced analytics
    • approaches to enhance patient stratification, endpoint sensitivity, and personalized evidence generation
    • registries, natural history studies and other real world evidence solutions to inform early research and development strategies
  • Drive the COA-related real-world evidence strategy to increase differentiation of assets and de-risk clinical trial outcomes, reduce complexity in evidence generation and support product value demonstration by way of the patient disease strategy for each indication and asset.
  • Advance conceptual modeling and dossier authoring using digital capabilities.
• Clinical Development, Regulatory and Payer Excellence
  • Identify, develop and implement next generation capabilities to advance COA value and evidence generation and recognition.
  • Ensure patient-driven outcomes strategies are industry leading and embedded in clinical trial design, aligned with global regulatory and HTA expectations.
  • Ensure digital solutions for COAs (eg, ePRO/DBM) are effectively integrated into clinical trials in a manner that reflects ease of implementation and a positive experience for trial sites and patient participants.
  • Lead the development of evidence packages that include COAs, digital endpoints, and RWE for global regulatory and payer submissions.
  • Partner with Regulatory Affairs to engage with health authorities on the qualification of novel digital and patient-centric measures and expand PED related evidence generation value recognition.
  • Collaborate directly with the Head of Market Access to establish highly effective strategies that link outcomes to value assessments across key markets.
• External Engagement
  • Represent Sanofi in global consortia, regulatory workshops, and scientific forums 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 for patients.
  • Drive Sanofi’s recognized thought leadership internally and externally in patient driven outcomes solutions and act as a key leader in evolving integrated patient engagement across the company.

Education

• Advanced degree in a relevant discipline related to health economics, qualitative and quantitative research (COAs).

Qualifications

• 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 implications of integrating real-world evidence.
• Significant demonstrated experience in digital innovation related to COA; including evidence of having successfully driven innovation for value creation.
• Proven track record of successful submissions incorporating patient-centered outcomes.
• Recognized within industry as a thought leader in this domain.
• Experience working in a global, matrixed environment.

Skills

• Deep understanding of clinical development, regulatory science, and clinical outcomes and health economics.
• Expertise in digital health technologies, AI/ML applications.
• Strong leadership, communication, and cross-functional collaboration skills.