Senior Scientist, Toxicology

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.

The individual also will possess the attributes and interest to expand their career toward a broader strategic Nonclinical Drug Safety role. This could include development toward future opportunities as the nonclinical safety lead on discovery or clinical development programs.

• 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.
• 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.

PhD in toxicology, pharmacology, pharmaceutical sciences, or related scientific discipline.

• Strong interest in collaborating with 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

• GLP Study Director experience
• Familiarity with outsourced study monitoring
• Demonstrated understanding of Good Laboratory Practices (US FDA 21 CFR Part 58)
• Familiarity with ICH safety guidelines

• Animal Handling, Contract Research Organizations (CROs), Data Evaluation, Detail-Oriented, Experimentation, Exploratory Research, Good Laboratory Practices (GLPs), In Vivo Models, Laboratory Research, Pre-Clinical Developments, Report Preparation, Situational Leadership, Study Directing, Study Monitoring, Timeline Management, Toxicological Risk Assessment, Toxicology

US and Puerto Rico Residents Only:

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