Head of Nonclinical Safety Evaluation

Role Summary

Head of Nonclinical Safety Evaluation overseeing Toxicology and Pathology functions to drive nonclinical safety strategies across Moderna’s mRNA pipeline and platform technologies. Lead a multidisciplinary team to ensure scientific rigor, regulatory compliance, and integrated risk assessment from discovery through clinical development. Build team capabilities and collaborate with leaders across the organization to support a diverse early- and late-stage pipeline.

Responsibilities

• Lead 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 at all stages of drug development.
• Apply in-depth knowledge of nonclinical safety disciplines and integrate with other areas of the business to differentiate Moderna.
• Evaluate nonclinical safety challenges in dynamic environments and develop innovative solutions with thorough analysis.
• Manage a team across various levels, supporting career growth and professional development.
• Provide strategic oversight on nonclinical safety strategies for discovery and development projects.
• Design, execute, and critically analyze nonclinical safety studies across multiple species, collaborating with study monitors and partner functions; support extractable/leachable and impurity qualification.
• Collaborate cross-functionally to ensure holistic safety assessments; participate in regulatory interactions and governance meetings when nonclinical data affect strategy.
• Review, edit, and author nonclinical submission documents and regulatory interactions; align toxicology with clinical development plans and regulatory strategies.
• Oversee preparation and presentation of nonclinical safety data for teams and partners.
• Maintain scientific visibility through publications, conferences, and engagement with external experts.
• May serve as an independent contributor for select discovery or pipeline programs as a Toxicology representative.

Qualifications

• DVM (ACVP board certification preferred) and/or PhD with 15+ years overseeing nonclinical safety in pharmaceutical development; experience with nucleic acid-based, nanoparticle modalities, immune-modulating therapeutics, oncology, or infectious disease vaccines.
• Distinguished reputation as a Toxicology expert in the global scientific community.
• Experience leading Toxicology representatives on drug development programs and designing nonclinical toxicology strategies and studies for clinical development and regulatory submissions.
• Mentoring/management experience for developing nonclinical safety strategies.
• Direct experience writing and critiquing nonclinical sections of regulatory submissions and interacting with regulatory agencies.
• Familiarity with regulatory guidelines for nonclinical safety studies.
• Strong people management, teamwork, and creative problem-solving abilities.
• Outstanding written and verbal communication; ability to deliver clear presentations to internal and external stakeholders.
• Attention to detail, quality, and timely delivery in a fast-paced environment.
• Proven track record influencing research strategies and a desire to contribute to a high-growth, transformational company.

Skills

• Nonclinical toxicology and safety pharmacology
• Genotoxicity, developmental and reproductive toxicology, carcinogenicity
• Regulatory writing and submissions (INDs/CTAs/BLAs/MAAs)
• Cross-functional collaboration and regulatory affairs
• Strategic leadership and people management
• Scientific communication and presentation

Education

• DVM or PhD required; ACVP board certification preferred

Additional Requirements

• Willingness to collaborate across departments and participate in regulatory interactions as needed.