Global Head, Regulatory Science — Model-Enabled Development, Real World Evidence and Novel Endpoints

Global Head, Regulatory Science Model-Enabled Development, Real World Evidence and Novel Endpoints Location: Morristown, NJ About the Job Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions. The Global Head, Regulatory Science Model-Enabled Development, Real World Evidence & Novel Endpoints serves as a specialized center of excellence within Sanofi's Regulatory framework, driving innovation in regulatory science through advanced model-informed approaches, real world evidence and novel endpoint development. We accelerate drug development timelines by providing expert guidance on Model-Enabled Drug Development frameworks, regulatory validation of new endpoints, real-world evidence data and cutting-edge regulatory strategies across therapeutic areas. We bridge the gap between R&D innovation and regulatory acceptance, partnering closely with Translational Medicine, Clinical Development, Biostatistics, and other key functions to ensure regulatory considerations are integrated early in the development process. With a commitment to Sanofi's "Take the Lead" values, particularly in "Leading Together" and "Being Bold," our mission is to establish GRA as a leader in new regulatory strategies while ensuring patient-focused outcomes and maintaining the highest standards of scientific rigor. Through strategic engagement with regulatory agencies and cross-functional collaboration, we enable faster, smarter development pathways that bring innovative healthcare solutions to patients worldwide. About Sanofi We are an 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 Provides Leadership and Strategic Vision: Accountable for organizational design, people development (supervising, coaching, mentoring), resource allocation (recruitment, retention, talent development, succession planning), and metrics for the expert unit. Demonstrates very strong leadership including influencing and negotiating skills, and conflict management and resolution. Capable of resolving and/or advising on very complex global organizational and regulatory/technical issues related to model-enabled development, regulatory real-world evidence and novel endpoints strategies. Demonstrates the knowledge and behaviors that model the Sanofi and GRA Values/Principles/Competencies. Establishes the team as a center of excellence for model-enabled regulatory strategies and submissions. Develops and Implements Innovative Regulatory Strategies: Oversees the development of comprehensive regulatory strategy frameworks for Model-Enabled Drug Development across all development phases, in collaboration with Global Regulatory Leads (GRLs) and other parts of GRA. Leads regulatory validation projects (e.g., C-Peptide endpoint validation, iBox ) from concept to approval, ensuring alignment with R&D product project timelines. Assures that positive and collaborative relationships are developed with R&D partners (TMU, Clinical Development, Biostatistics) to achieve implementation of appropriate model-enabled regulatory / real world evidence regulatory strategies. Ensures that regulatory considerations are integrated early in development projects and that risks are identified, communicated, and mitigated as necessary. Leads Strategic Engagement with Regulatory Agencies: Oversees strategic negotiations and engagement with worldwide Regulatory Agencies, including directly with FDA and EMA, on emerging model development topics, MIDD approaches, real-world evidence and novel endpoints. Develops and implements health authority engagement plans to advance acceptance of innovative regulatory strategies. Assures appropriate representation of Sanofi at Agency meetings and scientific working groups; assures that contacts with Agencies are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships with Agencies on cutting-edge regulatory science topics. Drives Knowledge Management and Capability Building: Provides vision and leadership for building specialized regulatory expertise in model-enabled development, real-world evidence approaches across the global GRA organization. Oversees the creation and dissemination of best practices, SOPs, training materials, and knowledge management platforms for such expertise and case studies. Partners with the Regulatory Capability and Learning Solution Lead to develop and deliver training curriculum and capability development programs. Monitors and communicates current Health Authorities thinking, regulatory trends, and paradigm shifts in model-enabled development, real world evidence and novel endpoints. Assures that the team takes a leadership role externally through participation in industry consortia, working groups, and professional associations. Ensures Excellence in Regulatory Submissions and Cross-Functional Collaboration: Oversees the preparation, review, and approval of model-enabled regulatory submissions, real evidence and novel endpoint validation packages to assure they meet appropriate quality standards and scientific rigor. Drives cross-functional project delivery efficiency through matrix collaboration with R&D counterparts. Assures that complex technical and regulatory issues related to modeling, simulation, and new endpoints are appropriately resolved with optimal solutions. Establishes clear governance and decision-making processes to enable efficient project execution and milestone achievement. About You Requirements Core Experience Minimum 10-15 years of regulatory affairs experience with demonstrated progression in regulatory roles and successful regulatory authority interactions. Direct experience with Model-Informed Drug Development (MIDD), pharmacometrics, modeling and simulation, and/or novel endpoint development is highly desirable. Proven track record of successful regulatory submissions involving advanced modeling approaches or innovative endpoints. Leadership Background Demonstrated leadership experience in building and developing specialized teams, including organizational design, people leadership and development (supervising, coaching, mentoring), recruitment, retention, talent management and succession planning. Experience establishing centers of excellence or expert units is highly valued. Ability to lead through influence in a matrix organization and drive cross-functional collaboration. Technical and Regulatory Expertise Strong knowledge of Model-enabled frameworks (e.g., FDA MIDD Pilot Program), regulatory pathways for novel endpoint validation, and key Agency thinking and trends in regulatory science innovation. Capable of resolving complex strategic technical and regulatory issues related to modeling, simulation, and endpoint development. Experience working with or for a Regulatory Health Authority is helpful but not essential. Education Bachelor's degree required. Advanced degree (Masters, Pharm D, PhD) in a quantitative science field (e.g., Pharmacometrics, Biostatistics, Pharmacology, Clinical Pharmacology, Translational Medicine, Computational Biology) or health sciences field, or equivalent is highly desirable. Communication Skills Demonstrated excellent communication and influencing skills internally and externally, with the ability to translate complex technical concepts for diverse audiences. Proven ability to build and maintain effective partnerships with health authorities, R&D functions, and external stakeholders including industry consortia. Strategic Thinking Demonstrated ability to assess regulatory risks and opportunities in emerging areas, develop pragmatic and innovative solutions that align with business objectives, and anticipate future regulatory trends. Demonstrated independence in thinking, anticipatory foresight, and ability to communicate effectively to broad, sophisticated, formal/informal, internal and external audiences. Collaborative Leadership Experience building and maintaining effective partnerships across functions (particularly with Translational Medicine, Clinical Development, Biostatistics, Medical Affairs) and with external stakeholders. Proven ability to drive knowledge sharing and capability building across organizations. Travel 10% travel expected, domestic and international. 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, whether its through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave. Sanofi Inc. 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. All 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. #J-18808-Ljbffr Initial Therapeutics, Inc.