Global Project Head, Toxicology

Job Title: Global Project Head, Toxicology

Location: Cambridge, MA

About the Job: Join Sanofi’s mission, where deep immunoscience meets AI‑powered research, and drive breakthroughs that could turn the impossible into possible for millions. We are a global biopharmaceutical leader committed to transforming medicine by developing innovative therapies across a broad range of therapeutic areas. Our Preclinical Safety organization plays a critical role in ensuring safety and scientific integrity from early discovery through regulatory submission and beyond.

The Global Project Head is a senior leadership role within Sanofi’s Global Preclinical Safety (PCS) organization, responsible for direct management and strategic oversight of a team of project toxicologists supporting the Sanofi drug development portfolio. This role demands exceptional scientific depth, outstanding cross‑functional communication, and the ability to lead a high‑performing team in a complex, fast‑paced global pharmaceutical environment.

• Provide strategic scientific oversight and direction for toxicology programs across multiple therapeutic areas and development stages.
• Ensure the development and execution of integrated, risk‑based toxicology strategies that are scientifically sound, regulatory‑compliant, and aligned with overall program objectives.
• Anticipate and proactively address emerging toxicological risks, proposing innovative and pragmatic solutions to enable program progression.
• Champion the application of new approach methodologies (NAMs), alternative testing strategies, and emerging science to continuously improve the quality and efficiency of preclinical safety assessments with the 3
  
  Rs framework.
• Contribute to the evolution of PCS strategy, policies, and best practices, helping to shape the future direction of the toxicology and the PCS function.

• Directly manage, mentor, and develop a team of project toxicologists, fostering a high‑performance culture grounded in scientific rigor, accountability, and continuous learning.
• Set clear performance objectives, provide regular and constructive feedback, and conduct formal performance evaluations in alignment with Sanofi’s talent management processes.
• Identify individual development needs and opportunities, actively supporting career growth and succession planning within the team.
• Recruit, onboard, and retain top scientific talent, ensuring the team has the capabilities required to meet current and future portfolio demands.
• Promote psychological safety, inclusion, and diversity within the team, creating an environment where all team members can contribute their best work.

• Ensure project toxicologists are fully prepared to support key governance milestones, including candidate selection, IND/CTA filings, clinical development transitions, and NDA/MAA/BLA submissions.
• Review and provide expert input on toxicology sections of regulatory documents, including briefing books, INDs, CTAs, NDAs, MAAs, IBs, BLAs and responses to health authority questions.
• Oversee the preparation and quality review of toxicology summaries, integrated summaries of safety, and other critical regulatory deliverables.
• Ensure timely and high‑quality delivery of all toxicology commitments in support of program timelines and governance decision points.
• Represent PCS at internal governance forums, program review meetings, and portfolio‑level discussions.

• Serve as a primary toxicology interface with cross‑functional teams, including Clinical Development, Regulatory Affairs, Drug Metabolism and Pharmacokinetics (DMPK), Pharmacology, Chemistry, Manufacturing and Controls (CMC), and Medical Safety.
• Build and maintain strong, trust‑based relationships with internal stakeholders across global functions and geographies.
• Communicate complex toxicological findings and risk assessments clearly to diverse audiences, including non‑specialist stakeholders, senior leadership, and governance committees.
• Collaborate with Regulatory Affairs to develop…