Global Project Head, Toxicology

Sanofi•Cambridge, MA

1d•Onsite

About The Position

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.

Requirements

PhD in Toxicology, Pharmacology, Biochemistry, Physiology, or a closely related scientific discipline.
Board certification (DABT or ERT) is strongly preferred.
Minimum of 15 years of progressive experience in pharmaceutical drug development, with a substantial and demonstrated focus on preclinical safety and toxicology.
Deep and current knowledge of global regulatory guidelines and requirements relevant to preclinical safety, including ICH M3(R2), ICH S1–S9, FDA, EMA, and PMDA guidance documents.
Demonstrated experience supporting drug candidates across multiple development stages, from early discovery through IND/CTA filing, clinical development, and NDA/MAA/BLA registration.
Proven track record of successfully managing, developing, and leading scientific teams in a pharmaceutical or biotechnology environment.
Hands-on experience contributing to and reviewing toxicology sections of major regulatory submissions (IND, NDA, MAA, or equivalent).
Exceptional written and verbal communication skills, with demonstrated ability to present complex scientific information clearly to diverse audiences, including senior executives and health authorities.
Demonstrated ability to work effectively in a highly matrixed, global organization, building strong cross-functional partnerships and influencing without direct authority.
Up to 20% domestic and international travel.

Nice To Haves

Experience across multiple therapeutic areas (e.g., oncology, rare diseases, immunology, cardiovascular, neuroscience).
Experience in executing novel, innovative toxicology strategies, such as in vitro-only preclinical safety packages to enable clinical development.
Direct experience with health authority interactions and meetings (e.g., FDA Type A/B meetings, EMA scientific advice).
Familiarity with new approach methodologies (NAMs), in vitro/in silico safety assessment tools, and 3Rs principles.
Experience in biologics, gene therapy, cell therapy, or other modalities beyond small molecules.
Track record of scientific publications, presentations at major conferences, or contributions to industry working groups (e.g., PhRMA, EFPIA, ICH expert working groups).
Experience working in a global, multicultural organization with cross-regional team management responsibilities.

Responsibilities

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 3Rs 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.
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.
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, clear, and authoritative scientific input.
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, ensuring toxicology perspectives are integrated into broader development strategies.
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 proactive regulatory strategies and to prepare for and participate in health authority interactions, including FDA, EMA, PMDA, and other global agencies.
Partner with external CROs, academic institutions, and industry consortia to leverage external expertise and advance Sanofi's scientific capabilities.
Maintain and apply deep expertise across core toxicology disciplines, including general toxicology, genetic toxicology, reproductive and developmental toxicology, carcinogenicity, immunotoxicology, and safety pharmacology.
Stay current with evolving regulatory guidelines (ICH, FDA, EMA, OECD) and proactively integrate new requirements into program strategies.
Contribute to internal scientific forums, publications, and external conferences, representing Sanofi as a thought leader in preclinical safety.
Drive continuous improvement initiatives within PCS, identifying opportunities to enhance scientific quality, operational efficiency, and regulatory outcomes.