The Opportunity:

We are seeking an experienced senior toxicologist, who combines scientific excellence with strategic leadership, for our Toxicology group within the Nonclinical Development and Clinical Pharmacology (NDCP) Department, to work in close collaboration with Research and Development colleagues on new and ongoing portfolio projects. Working within a highly collaborative, cross-functional organization, this role provides toxicology leadership from early research through all stages of clinical development, ensuring that safety assessments enable informed development decisions and global regulatory filings. The successful candidate will:

• Lead nonclinical safety strategy for multiple drug development programs spanning both small molecules and biologics.

• Serve as the toxicology representative on cross-functional Research and Development project teams, providing scientific guidance and influencing development strategy.

• Design, oversee, interpret, and communicate toxicology studies that support candidate selection, IND-enabling activities, and regulatory submissions.

• Author and review regulatory documents and ensure compliance with GLP, ICH, and global regulatory requirements.

• Provide expert interpretation of toxicology data within the context of the current scientific approaches/best practices, project objectives, and benefit-risk assessment.

• Lead nonclinical development sub-teams, mentor colleagues, and contribute to departmental strategy and process improvements.

• Collaborate with investigative toxicology team to drive mechanistic studies for target-, pathway- or off-target toxicities using in vitro and in vivo studies, including emerging new approach methodologies (NAMS) such as cell- and organoid-based assays and advanced imaging analyses.

• Drive innovation, solve complex scientific problems, and effectively manage multiple programs in a fast-paced environment.

Required Skills, Experience and Education:

• PhD in Toxicology or a related discipline with 10+ years, or M.S. degree with 15+ years, of relevant experience in the biopharmaceutical industry; DABT certification is desirable.

• Deep expertise in nonclinical safety assessment for small molecules and other modalities.

• Strong understanding of toxicology study design, GLPs, global regulatory requirements, with experience interacting with global regulatory authorities.

• Proven ability to lead cross-functional teams, influence strategy, and communicate effectively across scientific disciplines to resolve complex safety questions and support project decision-making.

• Strong scientific background and scientific aptitude with excellent critical thinking skills.

Preferred Skills:

• Expertise in integrating mechanistic, translational, and biomarker-based safety assessments into nonclinical development programs.
• Familiarity with impurity risk assessment, product quality, occupational and/or environmental toxicology, or in silico/computational toxicology.

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