Senior Director, Nonclinical Safety Evaluation

The Role

At Moderna, we deliver the greatest possible impact to people through mRNA medicines. We foster a dynamic, diverse, and innovative workplace where every individual’s contribution is vital.

We are seeking a seasoned scientific leader to serve in a senior leadership role within Nonclinical Safety Evaluation, providing strategic and operational leadership for Toxicology and Pathology. This role will serve on a leadership team with other nonclinical leaders and will partner closely with other cross‑functional stakeholders to ensure scientifically rigorous, acceptable, and compliant nonclinical safety strategies and data packages to support regulatory submissions.

The position will focus on products in Moderna’s Emerging and/or Established Systemic IV portfolio (Autoimmune, Immuno‑Oncology, and Rare Disease) and partner with Platform Science teams to support the safety evaluation and optimization of novel and existing technologies.

• Provide direct and matrix management of a high‑performing team of Toxicologists and Pathologists, fostering a culture of innovation, collaboration, excellence, and continuous learning.
• Provide integrated strategic leadership for Toxicology and Pathology in support of nonclinical safety evaluation of products from discovery to post‑marketing.
• Apply in‑depth knowledge of nonclinical safety disciplines—including general toxicology, safety pharmacology, genotoxicity, developmental, reproductive, and carcinogenicity—and how they integrate with other areas across the business.
• Evaluate non‑clinical safety challenges in complex or fast‑changing environments and lead development of innovative solutions with analytical and interpretive thinking.
• Provide strategic oversight and coaching to team members on the development of scientifically sound nonclinical safety strategies to support discovery and development projects.
• Lead design, execution, analysis, and reporting of GLP/non‑GLP nonclinical safety in vitro and/or in vivo studies in multiple species under the nonclinical safety assessment umbrella for the assigned therapeutic area(s).
• Oversee toxicology assessments supporting extractable/leachable and contaminant risk assessments and/or impurity qualification.
• Serve as a key scientific contributor in regulatory agency interactions, internal governance, and leadership meetings regarding nonclinical data package conclusions and impact on program and regulatory strategy.
• Use expert scientific and regulatory writing experience to review, edit, and author submission application documents (IND, CTA, BLA, MAA) and health authority interaction documents, ensuring integration of toxicology results with DMPK and pharmacology.
• Prepare and present nonclinical safety data for project teams, portfolio management, internal/external partners, and scientific groups in a concise and meaningful way.
• Maintain scientific awareness and presence internally and externally, leading initiatives to publish manuscripts and posters, present at scientific conferences, and engage with consultants, advisors, and the broader scientific community.
• Serve as an independent contributor and Toxicology Lead on selected discovery and/or pipeline programs.

• PhD and 11+ years overseeing nonclinical safety assessment activities in pharmaceutical development.
• Experience in nucleic acid‑based and nanoparticle modalities, immune‑modulating therapeutics, oncology, and/or infectious disease vaccine development.
• Demonstrated management, mentorship, and coaching of colleagues in negative‑clinical and toxicology roles on drug development programs.
• Proficiency in designing and executing nonclinical toxicology strategies and GLP/non‑GLP studies to support clinical development and regulatory submissions.
• Experience in writing, reviewing, and critiquing nonclinical sections of regulatory submission documents and interacting with regulatory agencies.
• Strong knowledge of regulatory guidelines for nonclinical safety studies.
• Outstanding written and verbal communication skills with the ability to deliver clear presentations for internal and external stakeholders.
• Attention to…