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

Job title

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

Morristown, NJ

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.

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.

• 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…