Nonclinical Toxicology Study Monitoring Scientist

Role: Nonclinical Toxicology Study Monitoring Scientist supporting safety assessment of large and small molecule modalities, including cell and gene therapies. Responsibilities: develop and review study protocols, monitor outsourced nonclinical safety studies at CROs via on-site and remote oversight, ensure study conduct aligns with GLP and regulatory standards, identify and resolve operational or scientific issues, prepare monitoring reports, manage multiple concurrent studies, and support CRO qualification and vendor oversight. Requirements: Master’s or Bachelor’s in life sciences with 3+ or 4+ years of relevant experience; hands-on in vivo laboratory experience; knowledge of GLP and nonclinical safety assessment; strong organizational, scientific, and communication skills. Preferred: prior CRO study monitoring experience, digital/AI tool familiarity, and regulatory documentation support. High-Value: supporting safety studies for biologics, gene therapies, or new modalities; involvement in IND-enabling or early clinical development phases; focus on cross-functional collaboration, scientific oversight, and vendor management. Work Setup: hybrid or on-site in Boston, with 30–50% travel.