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. Position Summary 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. Key Responsibilities Strategic Toxicology Leadership 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 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. 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. 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. Cross‑Functional Collaboration and Stakeholder Engagement 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 proactive regulatory strategies and to prepare for and participate in health authority interactions. Partner with external CROs, academic institutions, and industry consortia to leverage external expertise and advance Sanofi’s scientific capabilities. Scientific Excellence and Innovation 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. Required Qualifications 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 focus on preclinical safety and toxicology. Deep and current knowledge of global regulatory guidelines and requirements relevant to preclinical safety. Demonstrated experience supporting drug candidates across multiple development stages. Proven track record of successfully managing, developing, and leading scientific teams. Hands‑on experience contributing to and reviewing toxicology sections of major regulatory submissions. Exceptional written and verbal communication skills, with the ability to present complex scientific information clearly to diverse audiences. Demonstrated ability to work effectively in a highly matrixed, global organization. Travel up to 20% domestic and international. Preferred Qualifications Experience across multiple therapeutic areas (e.g., oncology, rare diseases, immunology, cardiovascular, neuroscience). Experience executing novel, innovative toxicology strategies, such as in‑vitro‑only preclinical safety packages. Direct experience with health authority interactions and meetings. 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. 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. Strong analytical and critical thinking skills, with the ability to synthesize complex datasets into clear, actionable conclusions. Exceptional communication and influence skills, including writing and presenting high‑impact presentations to senior leadership. Collaborative interpersonal effectiveness, fostering a culture of shared ownership and mutual respect. Leadership and people management skills, inspiring team development and engagement. Strategic thinking and decision‑making, balancing short‑term program needs with long‑term organizational priorities. Why Choose Us? Bring the miracles of science to life alongside a supportive, future‑focused team. Discover endless opportunities to grow your talent and drive your career, whether through promotion or lateral move, at home or internationally. Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family with a wide range of health and wellbeing benefits, including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender‑neutral parental leave. Salary Range: $232,500.00 – $335,833.33 (based on experience). Employees may be eligible to participate in Company employee benefit programs. Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, gender identity, sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, genetic information or any other characteristic protected by law. #J-18808-Ljbffr