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

Location
:
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.

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.

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…