Associate Principal Scientist, Toxicology/Study Director

Job title: Associate Principal Scientist, Toxicology/Study Director

Job Description:

The Nonclinical Drug Safety department is seeking a motivated and talented toxicologist to conduct and/or monitor toxicity studies (GLP and non-GLP) as a Study Director or Study Monitor. Toxicologists at our Company are integral members and leaders of collaborative cross functional scientific teams, addressing challenges from early discovery to late development. Our toxicologists provide scientific leadership in the design and overall conduct of in vivo studies and integrate the findings from all contributing scientists into reports that characterize the safety profile of drug candidates.

Key Responsibilities

• Serve as the 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 that the study is in compliance with the protocol, amendments, Standard Operating Procedures, regulations, safety guidelines, and company policies and procedures.

• Critically analyze and interpret data. Integrate data from other areas (e.g., clinical pathology, pathology, toxicokinetics) in written reports used for regulatory submissions, and communicate results within established timelines.

• Ensure regulatory rigor, proactive risk identification, and timely study execution.

• Demonstrate enterprise mindset and strategic thinking, proactively identifying opportunities, anticipating challenges, and contributing to solutions aligned with Nonclinical Drug Safety organizational priorities.

• Build strong collaborative relationships and influences without authority, contributing to an inclusive team environment.

• Deliver high-quality results with accountability and agility, translating objectives into action while continuously improving, embracing change, and demonstrating leadership.

• As needed, lead and/or participate in method development, inter-group initiatives, and various related scientific projects.

Education

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

Requirements

• Minimum of 8 years of relevant experience.

• Minimum of 5 years as a Study Director in pharma, biotech, or at a CRO.

• General toxicology GLP Study Director experience with varied models, routes of administration, and study designs.

• Demonstrated understanding of Good Laboratory Practices (US FDA 21 CFR Part 58)

• Strong interest in collaborating with diverse cross-functional teams and communicating openly and often with colleagues.

• Strong listening and leadership skills

• Ability to communicate clearly using verbal and written formats, including presentations

• Preferred

• GLP Study Director experience with varied modalities (e.g. biologics and small molecule therapeutics)

• Familiarity with outsourced study monitoring

• Familiarity with ICH safety guidelines

Required Skills

• Animal Studies, Effective Written Communication, Evaluate Information, Good Laboratory Practices (GLPs), Oral Communications, Proactive Thinking, Study Directing, Study Monitoring, Teamwork, Toxicology