Associate Principal Scientist, Toxicology/Study Director

Key Responsibilities

• Serve as single point of control (Study Director) on assigned acute through chronic general toxicology studies across all modalities.
• Interact with technical, veterinary, and scientific staff to ensure study compliance with protocol, amendments, SOPs, regulations, safety guidelines, and company policies.
• Critically analyze and interpret data; integrate clinical pathology, pathology, toxicokinetics into regulatory submission reports; communicate results within established timelines.
• Ensure regulatory rigor, proactive risk identification, and timely study execution.
• Demonstrate enterprise mindset and strategic thinking; proactively identify opportunities/challenges and contribute solutions aligned with Nonclinical Drug Safety priorities.
• Build collaborative relationships and influence without authority; support inclusive team environment.
• Deliver high-quality results with accountability and agility; translate objectives into action and continuously improve.
• Lead and/or participate in method development, inter-group initiatives, and related scientific projects (as needed).

Education

• Master’s degree with training in toxicology, pharmacology, or related discipline.

Requirements

• Minimum 8 years relevant experience.
• Minimum 5 years as a Study Director in pharma, biotech, or CRO.
• GLP General Toxicology Study Director experience with varied models, routes, and study designs.
• Demonstrated understanding of GLP (US FDA 21 CFR Part 58).
• Strong interest in cross-functional collaboration and open communication.
• Strong listening and leadership skills.
• Ability to communicate clearly (verbal and written, including presentations).

Preferred

• GLP Study Director experience with varied modalities (e.g., biologics, small molecules).
• Familiarity with outsourced study monitoring.
• Familiarity with ICH safety guidelines.

Required Skills

Animal studies; effective written communication; evaluate information; GLPs; oral communications; proactive thinking; study directing; study monitoring; teamwork; toxicology.