Senior Director -Project Toxicologist - Clinical Pharmacology and Safety Sciences (Boston or Gaithersburg)

Role: Senior Project Toxicologist specializing in regulatory toxicology and safety pharmacology within a global biopharma setting, supporting late-stage clinical development and marketed products across multiple therapy areas such as Oncology, Respiratory, and Immunology. Responsibilities: develop and execute global toxicology strategies to ensure safety and successful marketing approval; provide expertise in non-clinical safety assessments; communicate risk assessments and inform decision-making; coach teams through regulatory submissions and defend safety data; maintain regulatory compliance knowledge; evaluate in-licensing safety profiles. Requirements: PhD and/or DABT in Biology, Toxicology, Pharmacology, or related field; 10+ years of experience in project toxicology within pharma/biotech, with a track record across modalities like small molecules, peptides, and oligonucleotides; proven leadership and mentoring abilities; excellent communication and cross-functional collaboration skills. HighValue: late-phase clinical and marketed product support, global regulatory strategy, multi-therapy experience, seasoned in safety assessment and regulatory defense. WorkSetup: on-site in Kendal Square Waltham, MA or Gaithersburg, MD, with a flexible, collaborative in-person work environment.