Introduction & Purpose

The Director of Toxicology will be part of the Preclinical Development group, supporting small molecule drug development and providing scientific expertise and leadership in the safety assessment of all programs—from lead identification through clinical development. The candidate is expected to work in a highly collaborative team environment, playing a pivotal role at each stage of preclinical and clinical development.

Essential Responsibilities & Scope of the Job

• Provide expert support, guidance, and strategy on project safety assessments, with a specific focus on discovery and IND-stage small molecule projects.

• Serve as the key resource for toxicology, providing scientific knowledge and expertise to cross-functional project teams.

• Develop overall toxicology strategy and plans for lead candidates based on the clinical development plan.

• Oversee preclinical toxicology studies conducted at multiple Contract Research Organizations (CROs).

• Design and execute investigative toxicology studies, based on off- and on-target safety profiles of candidate drugs.

• Initiate appropriate processes for contract implementation, protocol development, and timeline optimization for toxicology studies.

• Monitor toxicology studies to ensure accuracy, compliance, and timely execution; audit raw data, review draft reports, and finalize them as submission-ready documents for regulatory authorities.

• Proactively respond to study issues and resolve problems in collaboration with the study director.

Internal and External Communication

• Prepare verbal and written summaries for internal discussions.

• Collaborate with the Preclinical Development team to develop optimal strategies to address specific safety concerns and partner with project teams.

• Review and/or author toxicology and/or safety pharmacology sections of regulatory documents (e.g., pre-IND briefing documents, INDs, IBs) and ensure regulatory compliance.

• Represent the company at meetings with regulatory agencies.

• Present summary data to project teams and senior leadership.

Position Qualifications (Knowledge, Skills, Abilities, Education, Experience)

• Ph.D. in Toxicology, Pathology, Physiology, Biochemistry, or a related biological science discipline, with an emphasis on small molecules preferred.

• DVM/Ph.D. or DVM with Board Certification in Veterinary Anatomic Pathology (ACVP) and/or Toxicology (DABT) is highly desirable.

Additional Requirements & Experience

• 10+ years’ experience in toxicology small molecule drug development within the biotech/pharma industry.

• Demonstrated knowledge of global regulatory requirements and expectations for nonclinical safety assessment packages supporting first-in-human clinical development and product registration.

• Thorough knowledge of GLP, ICH, and other global regulatory guidelines.

• Experience in filing multiple INDs is required; experience in filing NDAs is a plus.

• In-depth understanding of toxicology and/or toxicologic pathology with experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.

• Experience supporting project teams as the toxicology representative.

• Excellent oral and written communication skills.

• Additional expertise in specific toxicology areas (e.g., developmental and reproductive systems toxicology, endocrine systems toxicology, toxico-kinetics/dynamics simulation analyses) is a strong plus.