Head of Nonclinical Safety Evaluation

Role Summary

Head of Nonclinical Safety Evaluation overseeing Toxicology and Pathology functions, driving nonclinical safety strategies across the mRNA pipeline and platform technologies, with leadership of a multidisciplinary team to ensure scientific rigor, regulatory compliance, and integrated risk assessment from discovery through clinical development.

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 drug development stages.
• Apply deep knowledge of nonclinical safety disciplines and integrate with other business areas to differentiate Moderna.
• Evaluate safety challenges in dynamic environments and direct development of innovative solutions.
• Manage a team across various levels, supporting career growth and professional development.
• Provide strategic oversight and coaching on nonclinical safety strategies for discovery and development projects.
• Design, execute, and analyze nonclinical safety studies across species; oversee extractable/leachable and impurity risk assessments.
• Collaborate cross-functionally to ensure holistic safety assessments; represent nonclinical data in regulatory and governance discussions.
• Review and author regulatory submission documents and health authority interactions; align toxicology with clinical plans and regulatory strategies.
• Oversee preparation and presentation of nonclinical safety data for teams and partners.
• Publish and present scientifically; engage with external experts and the broader scientific community.
• May also serve as an independent contributor for select discovery/pipeline programs as a Toxicology representative.

Qualifications

• DVM (ACVP board certification preferred) and/or PhD with 15+ years overseeing nonclinical safety in pharmaceutical development.
• Distinguished reputation as a Toxicology expert.
• Experience managing toxicology representatives on drug development programs and designing nonclinical strategies.
• Experience mentoring and developing others in nonclinical safety strategies.
• Direct 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, teamwork, and problem-solving skills; clear and concise communication.
• Attention to detail, quality, and timely delivery; ability to adapt in fast-paced environments.
• Track record of impacting research strategies and a desire to contribute to a high-growth company.

Skills

• Nonclinical safety disciplines; toxicology, safety pharmacology, genotoxicity, developmental and reproductive toxicology, carcinogenicity.
• Regulatory writing and health authority interactions; IND/CTA/BLA/MAA submission preparation.
• Cross-functional collaboration; strategic leadership; scientific communication; program oversight.

Education

• DVM and/or PhD as indicated in qualifications.