Global Head of Clinical Data and Business Strategy

• Job Title:

• 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.

• About Sanofi
• We're an R D-driven, AI-powered biopharma company committed to improving people's 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 people's lives.
• Main responsibilities include:
• 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
• Why 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, whetherit'sthrough 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 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, 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 ​ \#LI-SA \#LI-Onsite​ \#vhd

• Pursue
• _progress_
• , discover
• _extraordinary_
• Better is out there.

Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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. _North America Applicants Only_ 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. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)