Global Head of Clinical Data and Business Strategy

Global Head of Clinical Data and Business Strategy Location: Morristown, NJ or Cambridge, MA About the Job Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI‑powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. At Sanofi, we chase the miracles of science to improve people’s lives. We are accelerating our modernization journey, supporting our Play to Win strategy to become more focused, integrated, agile, and efficient. The current wave of digital technologies in artificial intelligence and Generative AI offers enormous opportunities to transform clinical development and redefine what’s possible in drug discovery and patient care. To harness the power of emerging technologies and accelerate digital transformation, we created the Clinical Data & AI Processing (CDAIP) department within Clinical Sciences and Operations. The Global Head of Clinical Data Technology and Business Strategy is a pivotal business leader who will drive our clinical data technology roadmap and business strategy as we transform clinical data processing and analytics, enhancing drug development processes and patient outcomes. This role requires deep expertise in patient data generation, collection, and ingestion, combined with a visionary perspective on how AI can revolutionize these areas—from initial data capture through final delivery of clinical databases supporting regulatory submissions. We seek an exceptional leader with a strong foundation in clinical development and the proven ability to lead transformational change through AI integration. This leader will oversee three critical pillars: Clinical Data Technology, Systems/Tools/Processes, and Business Strategy—playing a key role in advancing Sanofi's digital transformation and ensuring our data infrastructure supports breakthrough innovations in patient care. Main Responsibilities Clinical Data Technology Leadership Partner with clinical development teams to ensure seamless data flow and study execution across therapeutic areas Collaborate with the Global Head of AI‑Driven Innovations to develop and execute a comprehensive strategy that revolutionizes traditional clinical data processing through AI‑powered solutions Enable real‑time access to clinical data from increasingly diversified sources, reimagining data management with a complex, multi‑disciplinary approach to data quality and intelligence generation Define and execute the strategic roadmap for AI‑powered clinical data flows, leading process optimization initiatives that enhance efficiency and data quality Establish and maintain reinforced governance frameworks for system validation, change management, quality assurance, and regulatory compliance Drive standardization and innovation in clinical database design aligned with CDISC standards and regulatory requirements Embracing increasingly diversified patient data sources Partner with Procurement, Digital, and Vendor Excellence teams to develop and execute strategic partnerships with technology providers, CROs, and academic institutions Lead initiatives to enable real‑time access to eHR data, patient‑generated data from wearables, mobile health applications, and other emerging sources Evaluate and integrate innovative data collection methodologies that enhance patient engagement and data richness Ensure data interoperability and integration across traditional and novel data sources Business Strategy Leadership Define and execute comprehensive business strategy and robust sourcing strategies in the highly dynamic digital transformation environment Represent CDAIP in cross‑functional strategic planning and enterprise‑wide digital transformation initiatives Drive thought leadership through industry conferences, publications, and collaborative forums Establish and maintain relationships with regulatory agencies, industry consortia, and external partners Team Leadership Foster a culture of innovation, continuous learning, improvement, and technical excellence within the Clinical Data Technology & Business Strategy team Provide strategic direction, mentorship, and career development for diverse, high‑performing teams Promote a collaborative work environment that encourages creativity, problem‑solving, and cross‑functional partnership Stakeholder Management Collaborate with senior leadership to align department goals with overall company strategy and Play to Win objectives Partner with Clinical Operations, Digital, EGDS, Regulatory, Vaccine teams to ensure seamless integration of AI and data processing solutions into existing workflows Build strong relationships across functions, geographies, and organizational levels Compliance and Ethics Ensure all AI and data processing activities comply with relevant regulations, ethical standards, and industry best practices (FDA, EMA, ICH‑GCP) Develop and maintain robust data governance, privacy, and security protocols related to AI and advanced analytics Stay informed about evolving regulations and industry standards related to AI in healthcare and clinical development Champion responsible AI practices and ethical data stewardship across the organization Lead risk management strategies for data integrity, patient privacy, and regulatory compliance About YOU Basic Qualifications Advanced degree (Master’s or PhD) in Life Sciences, Computer Science, Data Science, Biostatistics, or related field. Candidates with a Bachelor’s degree AND extensive leadership experience may also be considered. 10+ years of progressive experience in leadership roles within clinical development, data management, biostatistics, AI, or related fields in the pharmaceutical or healthcare industry Extensive expertise in clinical data management and analytics throughout the clinical development lifecycle Strong knowledge of clinical database design, data management planning, and CDISC standards (SDTM, ADaM, CDASH) Deep understanding of clinical trial processes, regulatory requirements (FDA, EMA, ICH‑GCP), and data governance principles Proven track record of leading transformational change and driving innovation in complex, global organizations Excellent leadership, communication, and interpersonal skills with the ability to inspire teams and influence stakeholders at all levels Benefits The salary range for this position is: $232,500.00 - $335,833.33. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs. Equal Opportunity & Inclusive Workforce Statement Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership, or civil union status; sex; gender identity or expression; sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #J-18808-Ljbffr Mass Digital Health