Global Head of Clinical Data and Business Strategy

Job Title:Global Head of Clinical Data and Business StrategyLocation:Morristown, NJ or Cambridge, MAAbout The JobJoin the engine of Sanofis mission where deepimmunosciencemeets bold, AI-powered research. In R&D,youlldrive 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 areasfrom 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 Strategyplaying a key role in advancing Sanofi's digital transformation and ensuring our data infrastructure supports breakthrough innovations in patient care.About SanofiWerean R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.Main Responsibilities IncludeClinical Data Technology Leadership:Partner with clinical development teams to ensure seamless data flow and study execution across therapeutic areasCollaborate with the Global Head of AI-Driven Innovations to develop and execute a comprehensive strategy that revolutionizes traditional clinical data processing through AI-powered solutionsEnable real-time access to clinical data from increasingly diversified sources, reimagining data management with a complex, multi-disciplinary approach to data quality and intelligence generationDefine and execute the strategic roadmap for AI-powered clinical data flows, leading process optimization initiatives that enhance efficiency and data qualityEstablish and maintain reinforced governance frameworks for system validation, change management, quality assurance, and regulatory complianceDrive standardization and innovation in clinical database design aligned with CDISC standards and regulatory requirementsEmbracing Increasingly Diversified Patient Data SourcesPartner with Procurement, Digital, and Vendor Excellence teams to develop and execute strategic partnerships with technology providers, CROs, and academic institutionsLead initiatives to enable real-time access to eHR data, patient-generated data from wearables, mobile health applications, and other emerging sourcesEvaluate and integrate innovative data collection methodologies that enhance patient engagement and data richnessEnsure data interoperability and integration across traditional and novel data sourcesBusiness Strategy LeadershipDefine and execute comprehensive business strategy and robust sourcing strategies in the highly dynamic digital transformation environmentRepresent CDAIP in cross-functional strategic planning and enterprise-wide digital transformation initiativesDrive thought leadership through industry conferences, publications, and collaborative forumsEstablish and maintain relationships with regulatory agencies, industry consortia, and external partnersTeam LeadershipFoster a culture of innovation, continuous learning, improvement, and technical excellence within the Clinical Data Technology & Business Strategy teamProvide strategic direction, mentorship, and career development for diverse, high-performing teamsPromote a collaborative work environment that encourages creativity, problem-solving, and cross-functional partnershipStakeholder ManagementCollaborate with senior leadership to align department goals with overall company strategy and Play to Win objectivesPartner with Clinical Operations, Digital, EGDS, Regulatory, Vaccine teams to ensure seamless integration of AI and data processing solutions into existing workflowsBuild strong relationships across functions, geographies, and organizational levelsCompliance And EthicsEnsure 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 analyticsStay informed about evolving regulations and industry standards related to AI in healthcare and clinical developmentChampion responsible AI practices and ethical data stewardship across the organizationLead risk management strategies for data integrity, patient privacy, and regulatory complianceAbout YOUBasic 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 industryExtensive expertise in clinical data management and analytics throughout the clinical development lifecycleStrong 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 principlesProven track record of leading transformational change and driving innovation in complex, global organizationsExcellent leadership, communication, and interpersonal skills with the ability to inspire teams and influence stakeholders at all levelsWhy Choose Us?Bring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whetheritsthrough a promotion or lateral move, at home or internationally.Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.Takegood careof yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare,preventionand wellness programs and at least14 weeks gender-neutral parental leave.Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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, gender identity or expression; affectional or 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.#GD-SA#vhdAll compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.