Head of Nonclinical Safety Evaluation

OverviewThe Role: At Moderna, our mission is to deliver the greatest possible impact to people through mRNA medicines. We are seeking a seasoned scientific leader to serve as the Head of Nonclinical Safety Evaluation, overseeing Toxicology and Pathology functions. This role leads nonclinical safety strategies across Moderna’s mRNA pipeline and platform technologies, builds and directs a multidisciplinary team, ensures scientific rigor and regulatory compliance, and provides integrated risk assessment for programs from discovery through clinical development. The incumbent will play a key enterprise leadership role, planning organizational design and team structure to flexibly support a diverse early- and late-stage pipeline. Strong communication, innovative problem-solving, and comfort working in a dynamic, cross-functional environment are required.Here’s What You’ll DoLead and develop a high-performing team of toxicologists and pathologists, fostering innovation, collaboration, and excellence.Provide integrated strategic direction for Toxicology and Pathology to support nonclinical safety evaluation across all stages of drug development.Apply in-depth knowledge of nonclinical safety disciplines (general toxicology, safety pharmacology, genotoxicity, developmental and reproductive toxicology, carcinogenicity) and integrate with other business areas to differentiate Moderna.Evaluate nonclinical safety challenges in complex or fast-changing environments and drive development of innovative solutions.Lead and manage a team across a range of levels, supporting career growth and development.Provide strategic oversight and coach team members on nonclinical safety strategies in collaboration with platform and pipeline teams and the cross-functional Nonclinical Drug Development Sciences group.Oversee design, execution, and analysis of nonclinical safety studies in multiple species, and support toxicology assessments for extractable/leachable and impurity qualifications.Collaborate cross-functionally with research, clinical, DMPK, bioanalytical, operations, and regulatory teams; serve as a key voice in regulatory interactions and internal governance when nonclinical data influence program strategy.Apply expert scientific and regulatory writing to review, edit, and author submission documents (INDs, CTAs, BLAs, MAAs) and health authority documents; align toxicology with clinical development plans and regulatory strategies.Prepare and present nonclinical safety data concisely for project teams, portfolio management, and external partners.Maintain scientific awareness by publishing and presenting at conferences and engaging with the scientific community and consultants.May also serve as an independent contributor for select discovery and/or pipeline programs as a Toxicology representative.Here’s What You’ll Need (Minimum Qualifications)DVM (ACVP board certification preferred) and/or PhD with 15+ years overseeing nonclinical safety in pharmaceutical development. Preference for experience in nucleic acid-based and nanoparticle modalities, immune-modulating therapeutics, oncology, or infectious disease vaccines.A distinguished reputation as a Toxicology expert in the global scientific community.Experience serving as Toxicology lead/representative on drug development programs and designing nonclinical safety strategies and studies to support clinical development and regulatory submissions.Experience mentoring, coaching, and managing others on nonclinical safety strategies.Experience writing and reviewing nonclinical sections of regulatory submissions and interacting with regulatory agencies.Familiarity with regulatory guidelines for nonclinical safety studies.Strong people management and organizational development skills, with a passion for building teams.Outstanding written and verbal communication skills; ability to deliver clear presentations for internal and external stakeholders.Attention to detail, quality, and timeliness; ability to thrive in a fast-paced environment and adapt to changing data or strategy.Track record of influencing departmental and organizational initiatives to shape research strategies.Desire to contribute to a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Benefits and Well-BeingModerna emphasizes employee well-being with comprehensive benefits, including best-in-class healthcare coverage, fitness and mental health resources, lifestyle spending accounts, family planning and adoption benefits, generous paid time off, and savings/investment opportunities. Location-specific perks are also available.About ModernaSince 2010, Moderna has aspired to build the leading mRNA technology platform, enabling transformative medicines. We value diverse ideas and collaborations that advance patient care and global health.Moderna is recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.If you want to make a difference, visit /careers to learn about current opportunities.Our Working ModelModerna supports a 70/30 in-office work model to promote collaboration, mentorship, and innovation. Moderna is a smoke-free, alcohol-free, and drug-free workplace.Equal OpportunitiesModerna is an equal opportunity employer. We do not discriminate on race, color, sex, gender identity, age, religion, national origin, disability, veteran status, genetic information, sexual orientation, marital or familial status, or any other protected characteristic. To apply, meet the Basic Qualifications for the role and join our mission.Moderna is an E-Verify Employer in the United States. Qualified applicants will be considered without regard to criminal history where allowed by law.AccommodationsModerna offers reasonable accommodations to qualified applicants. If you require an accommodation during hiring or to perform the role, contact the Accommodations team at Control NoticeThis position may involve access to technology or data subject to U.S. export control laws. Employment is contingent upon the ability to access export-controlled information in accordance with U.S. law. Only U.S. persons are eligible to access such information without an export license; others may be considered if a license can be obtained. #J-18808-Ljbffr

Created: 2025-09-21