Global Project Head, Toxicology

About the role

Join the engine of Sanofis 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 peoples 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.

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.

Qualifications

• Education: PhD in Toxicology, Pharmacology, Biochemistry, Physiology, or a closely related scientific discipline. Board certification (DABT or ERT) is strongly preferred.
• Experience: Minimum of 15 years of progressive experience in pharmaceutical drug development, with a substantial and demonstrated focus on preclinical safety and toxicology.
• Regulatory Knowledge: Deep and current knowledge of global regulatory guidelines and requirements relevant to preclinical safety, including ICH M3(R2), ICH S1S9, FDA, EMA, and PMDA guidance documents.
• Drug Development Expertise: Demonstrated experience supporting drug candidates across multiple development stages, from early discovery through IND/CTA filing, clinical development, and NDA/MAA/BLA registration.
• People Management: Proven track record of successfully managing, developing, and leading scientific teams in a pharmaceutical or biotechnology environment.
• Regulatory Submissions: Hands-on experience contributing to and reviewing toxicology sections of major regulatory submissions (IND, NDA, MAA, or equivalent).
• Communication Skills: Exceptional written and verbal communication skills, with demonstrated ability to present complex scientific information clearly to diverse audiences, including senior executives and health authorities.
• Collaboration: Demonstrated ability to work effectively in a highly matrixed, global organization, building strong cross-functional partnerships and influencing without direct authority.
• Travel: up to 20% domestic and international

Preferred Qualifications

• 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.

Key Competencies and Skills

• Scientific and Technical:
  • Mastery of core toxicology disciplines and their application to drug development decision-making
  • Expert-level understanding of global preclinical safety regulatory frameworks
  • Ability to integrate toxicology data with broader pharmacology, DMPK, and clinical safety information to generate holistic safety assessments
  • Strong analytical and critical thinking skills, with the ability to synthesize complex datasets into clear, actionable conclusions
• Communication and Influence:
  • Exceptional oral and written communication skills, the ability to translate complex scientific findings into clear, concise, and compelling narratives for diverse audiences is a defining requirement of this role
  • Skilled at preparing and delivering high-impact presentations to senior leadership, governance committees, and external stakeholders
  • Ability to write and review high-quality scientific and regulatory documents with precision and clarity
  • Confident and credible communicator in high-stakes settings, including health authority interactions and executive briefings
• Collaboration and Interpersonal Effectiveness:
  • Highest collaborative leadership style actively seeks input, builds consensus, and fosters a culture of shared ownership and mutual respect
  • Demonstrated ability to navigate and influence in a complex, matrixed global organization
  • Skilled at building and sustaining productive relationships across functions, geographies, and organizational levels
  • Culturally aware and sensitive, with experience working effectively across diverse international teams
• Leadership and People Management:
  • Inspirational people leader with a genuine commitment to team development and employee engagement
  • Ability to set a clear vision, align team priorities with organizational goals, and drive accountability
  • Skilled at managing performance, navigating difficult conversations, and supporting team members through change
  • Resilient and adaptable, with the ability to lead effectively under ambiguity and in a fast-paced environment
• Strategic Thinking and Decision-Making:
  • Ability to think strategically across the portfolio, balancing short-term program needs with long-term organizational priorities
  • Sound scientific judgment and risk tolerance, with the ability to make and defend well-reasoned decisions under uncertainty
  • Sound scientific judgment and risk tolerance, with the ability to make and defend well-reasoned decisions under uncertainty