Kaiyu He
Associate Director, Toxicology @Stoke Therapeutics
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WORK HISTORY
Associate Director, Toxicology @Stoke Therapeutics
Boston, MA, US
Lead the nonclinical safety strategy, overseeing toxicology and safety pharmacology studies to deliver high‑quality safety packages.• Drive study design, data interpretation, and regulatory toxicology content for IND/NDA filings and agency interactions.• Build and manage a strong CRO network while setting toxicology priorities, resources, budgets, and timelines.• Partner cross‑functionally with Discovery, DMPK, CMC, Clinical, and Regulatory teams to align development strategy.• Stay ahead of advances in oligonucleotide safety science and represent the company with external partners and scientific stakeholders.
EDUCATION
Lanzhou University
Master's degree, Biochemistry and Molecular Biology
Michigan State University
Doctor of Philosophy (Ph.D.), Toxicology
SKILLS
ABOUT KAIYU HE
Board-certified Project Toxicologist (DABT) and Regulatory Toxicologist (RAC-Drug) with over ten years of expertise in toxicology and a proven record of publications.2. Specialized in the design, execution, and interpretation of nonclinical safety studies in alignment with GLP standards and ICH/FDA regulatory expectations, supporting IND submissions and fulfilling Post-marketing Requirements (PMRs). Broad expertise with a variety of therapeutic modalities, including small molecules, gene therapies, antisense oligonucleotides (ASOs), and small interfering RNAs (siRNAs), across multiple disease areas. Skilled in working with diverse animal models (e.g, rodents, NHPs, dogs, rabbits) and administration routes (e.g, oral, subcutaneous, intravenous, intrathecal, intraperitoneal). Proven ability to collaborate effectively with cross-functional teams in biotech and pharma settings, including discovery, CMC, DMPK, regulatory affairs, and clinical development. Highly motivated, detail-oriented, and adept at managing complex projects under tight timelines, with strong communication and leadership skills.
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