How You’ll Contribute
• Oversee non-GLP and GLP nonclinical safety studies across discovery and development-stage programs, with a focus on quality, execution, interpretation, and fit-for-purpose study design.
• Serve as the primary scientific reviewer for outsourced nonclinical safety studies, critically evaluating protocols, amendments, reports, and raw or interpreted data to ensure rigor, clarity, and appropriate conclusions.• Provide expert interpretation of toxicology studies, including general toxicology, safety pharmacology, genetic toxicology, and, where applicable, reproductive toxicology and carcinogenicity findings, highlighting key results, risks, trends, and development implications.
• Identify data gaps, inconsistencies, or study conduct issues, and work with internal and external teams to resolve them efficiently and scientifically.
• Participate actively in cross-functional team meetings to communicate study progress, interpret findings, and provide nonclinical safety input to broader program discussions.
• Partner closely with Chemistry, Biology, Translational Sciences, CMC, Regulatory Affairs, Clinical Development, other relevant functions and program teams to contextualize nonclinical safety findings and support next-step recommendations.
• Contribute to the planning and monitoring of nonclinical safety studies required to support candidate progression and regulatory submissions.
• Support authoring and review of nonclinical summaries, study interpretation sections, and regulatory documents, including materials supporting IND-enabling packages.
• Represent Nonclinical Safety Evaluation in cross-functional discussions, clearly communicating study outcomes, risks, and recommendations.
• Help maintain high standards for external study oversight, documentation, data review, and reporting practices across the function.
• Stay current on evolving toxicology methods, nonclinical safety expectations, and regulatory guidance relevant to RNAi and oligonucleotide therapeutics.