Global Project Head, Toxicology

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* Job Title:

** Global Project Head, Toxicology

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* Location:

** 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. As a global biopharmaceutical leader, we are committed to transforming the practice of medicine by developing innovative therapies across a broad range of therapeutic areas. Our Preclinical Safety organization plays a critical role in ensuring the safety and scientific integrity of our portfolio - from early discovery through regulatory submission and beyond.

** 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.

** Position Summary*
* The Global Project Head is a senior leadership role within Sanofi's Global Preclinical Safety (PCS) organization, responsible for the direct management and strategic oversight of a team of project toxicologists supporting the Sanofi drug development portfolio. This individual serves as a key scientific and operational leader, ensuring the successful design, execution, and communication of toxicology strategies that advance drug candidates through governance milestones, clinical development, and registration.

Operating at the intersection of science, strategy, and leadership, the Global Project Head plays a pivotal role in shaping the preclinical safety profile of Sanofi's pipeline. This role demands exceptional scientific depth, outstanding cross-functional communication, and the ability to lead and inspire a high-performing team in a complex, fast-paced global pharmaceutical environment. The incumbent is expected to model Sanofi's values
- ** Aim Higher, Act for Patients, Be Bold, and Lead Together**  - and to drive a culture of scientific excellence, accountability, and collaboration.

** Key Responsibilities*
* ** Strategic Toxicology Leadership*
* + Provide strategic scientific oversight and direction for toxicology programs across multiple therapeutic areas and development stages, from early discovery through regulatory submission.

+ 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 at Sanofi.

** Team Management and Development*
* + 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.

+ Manage resource allocation across the portfolio, balancing workload and priorities to ensure optimal team effectiveness and program support.

** Governance Milestone Support and Execution*
* + 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, providing relevant,…