Principal Scientist, Toxicologist​/Study Director

Principal Scientist, Toxicologist/Study Director Key Responsibilities

• Serve as Study Director (single point of control) for assigned acute through chronic general toxicology studies across all modalities; ensure compliance with protocol/amendments, SOPs, regulations, safety guidelines, and company policies.
• Critically analyze and interpret data; integrate clinical pathology, pathology, and toxicokinetics into written reports for regulatory submissions; communicate results on timeline.
• Ensure regulatory rigor, proactive risk identification, and timely study execution.
• Participate on cross-functional teams to investigate mechanisms of toxicity.
• Represent nonclinical safety on product development teams; oversee strategy/design of nonclinical safety studies and develop regulatory strategies and communications with global agencies.
• Demonstrate enterprise mindset and strategic thinking; collaborate to deliver solutions and contribute to an inclusive environment.
• Deliver high-quality results with accountability and agility; continuously improve and support larger initiatives.

• PhD and/or DVM with graduate/post‑graduate training in toxicology, pharmacology, or related discipline.

• 8+ years as a Toxicologist or Study Director in pharma/biotech/CRO.
• Demonstrated experience with GLP (US FDA 21 CFR Part 58).
• Strong collaboration and communication across cross‑functional teams; leadership and mentoring.
• Clear verbal and written communication (presentations/meetings).
• Expertise in immunology and/or biologics, including regulatory requirements and testing.

• Knowledge of biotherapeutics/large‑molecule drug development strategies.
• Experience with outsourced study monitoring.
• Toxicology expert on drug discovery/development teams.
• Representation of nonclinical safety in regulatory agency interactions.