Sr. Leader Discovery Toxicology

The Senior Director, Discovery Toxicology is responsible for providing scientific and strategic leadership to the Integrative Toxicology function within the Discovery & Translational Sciences (DTS) division. This role oversees the direction and execution of Investigative Toxicology efforts, with a focus on evaluating and mitigating safety risks associated with early-stage therapeutic targets. The position requires a strong foundation in discovery and preclinical toxicology, with the ability to interpret complex data across in vitro, in vivo, and human tissue-based models. The role plays a key part in enhancing the translational relevance of toxicological assessments and supports cross-functional collaboration to advance internal and client drug development programs.

This is a remote role.

 

Key Accountabilities

• Design and implement modern toxicology strategies to support all stages of discovery as well as new indications investigations during clients’ phased clinical studies and/or post-marketed therapeutics.

• Drive the integration of toxicology as practiced at Inotiv’s multiple sites into a single, coordinated network that operates with shared goals, stage-appropriate standards, and best practices.

• Lead mechanistic investigations using in vitro, in vivo, and ex vivo approaches.

• Contribute to the scientific advancement and programmatic inclusion of Novel Alternative Methods (NAM) in the Pharmacologic and Toxicologic assessment of therapeutics

• Evaluate species relevance to improve translatability of nonclinical findings to human risk.

• Collaborate cross-functionally with pharmacology, DMPK, pathology, bioinformatics, and clinical teams to integrate data and guide compound development.

• Contribute to the discovery and application of translational safety biomarkers to support preclinical-to-clinical transitions.

• Anticipate and mitigate safety liabilities early in the discovery process, including off-target effects and distinguishing adaptive from adverse responses.

• Mentor and develop a high-performing team of toxicology investigators and laboratory scientists.

• Represent Discovery Toxicology in internal project teams, governance forums, and external regulatory interactions, as needed.

• Monitor scientific and regulatory advancements to continuously innovate and evolve toxicology strategies.

• Lead a multidisciplinary team including Study Directors, Investigators, and Technical Scientists.

• Complete assigned all assigned training.

• All other duties as assigned.

• Other special projects and duties as assigned

Minimum Requirements

• PhD in Toxicology, Pharmacology, or a related biomedical science, with 15+ years of experience in discovery or investigative toxicology within the pharmaceutical, biotech, or CRO industry.

• Additional qualifications such as DVM or Board Certification in Pathology are strongly preferred.

• Proven expertise in designing and interpreting in vitro, in vivo, and ex vivo toxicology studies to investigate mechanisms of toxicity.

• Track record of successfully supporting drug discovery programs from hit identification through candidate nomination.

• Deep understanding of molecular and cellular toxicology, interspecies differences, drug metabolism, and mechanisms of human relevance.

• Experience in biomarker discovery and translational safety assessments is highly desirable.

• Strategic thinker with the ability to synthesize complex scientific data into actionable development plans.

• Strong leadership skills with experience managing and developing scientific teams.

• Excellent communication and cross-functional collaboration skills.

• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) is required.
   

Critical Success Factors                                                                                                                                                                

• Results Driven. Internal drive toward action to efficiently, timely, and accurately achieve results. Sets high but achievable standards for self and others. Seeks opportunities to improve process and outcomes. Constantly reviews performance to identify areas to develop.

• Efficient.   Takes responsibility for own time and effectiveness.  Identifies what needs to be done and does it before being asked or before the situation requires it.  Able to work things out without having to be shown too often. Seeks opportunities to contribute appropriately without direction.