Director, Study Quality and Compliance - Nonclinical Safety/Toxicology

Role: Oversee the Study Quality and Compliance team within the Preclinical Safety Toxicology line, focusing on study data management, SOPs, training, and archival processes. Objectives include modernizing team functions through implementing tracking, management, and data analytics software (e.g., Smartsheet), ensuring high-quality toxicology study data, and supporting regulatory submissions with SEND datasets. Responsibilities: lead strategic planning, oversee data management from internal and external studies, ensure compliance with GLP standards, and coordinate sample shipment and data transfer for biomarkers and digital slides. Qualifications: advanced degree in biological sciences with ≥10 years or BS with ≥15 years pharma experience, with prior GLP and toxicology study exposure, leadership experience, and strong communication and planning skills. Preferred: familiarity with data/program management tools and SEND regulations. High-value specifics include expertise in GLP toxicology studies, data analytics, regulatory data exchange (SEND), and managing cross-functional collaborations. Work setup: hybrid in Cambridge MA.