Director, Toxicology

About The Role

The Director, Toxicology Translational Science will serve as a scientific and strategic leader driving team and pipeline development at Tarsus, leveraging expertise in toxicology, safety pharmacology, and translational science to bridge discovery and clinical development from concept through IND‑enabling and early clinical studies.

• Subject Matter Expert in toxicology, safety pharmacology and nonclinical safety assessment across all Tarsus Programs
• Establish and maintain strong external partnerships with CROs, academic institutions and key opinion leaders
• Define and drive GLP- safety /toxicology strategies across programs to accelerate programs to FIH
• Oversee GLP and non‑GLP toxicology and safety pharmacology studies at CROs, ensuring scientific rigor, data integrity and regulatory compliance (GLP, animal welfare, and safety), SOPs, and technical study requirements
• Review and edit study protocols and reports to ensure scientific rigor, regulatory compliance (GLP, animal welfare, and safety), and high‑quality study interpretation
• Build out the Toxicology program and Bio‑analytics and biomarker capacity
• Author and review toxicology sections for regulatory submissions (IND, CTA, NDA/BLA, IBs and CSR)
• Represent toxicology in cross‑functional program teams and governance forums
• Maintain study timelines and ensure non‑clinical studies are conducted in accordance with overall program objectives
• Assist Non‑clinical Project Leaders in integrating and assembling toxicology data for regulatory submissions (e.g., IND, NDA, BLA)
• Build strong relationships with internal teams and external partners to ensure optimal decision‑making

• Partner with key internal experts across the company including Innovation Lab and Business Development (BD) for asset evaluation and development strategies, identifying toxicology risks and mitigation strategies
• Identify and implement innovative AI‑driven toxicology approaches including NAMs to support regulatory submission and interactions with regulatory agencies

• PhD, MD/PhD, DVM, or related field in Toxicology, Pharmacology, Biology; DABT or ERT certification preferred
• 12+ years in pharma or biopharma toxicology/pathology; preference for an individual with experience in ophthalmology
• Strong GLP and ICH guidance knowledge; experience with EMA/FDA CTA/IND submissions and regulatory interactions preferred
• Ability to develop comprehensive preclinical safety approaches with internal stakeholders; skilled in executive and agency presentations
• Experience managing outsourced studies; thrives in fast‑paced environments
• Excellent oral and written communication skills, including writing, reviewing and editing scientific documents
• Strong interpersonal skills, diplomacy, and positive‑influencing abilities
• Exceptional communication, influencing and partnering skills to drive decision‑making within a multi‑disciplinary, matrix teams
• Effective project management skills
• Strong presentation skills; must be able to provide succinct, strategic and actionable insights
• Proactive self‑starter who can lead work independently, with the ability to see the next step and anticipate issues
• Enterprise and entrepreneurial mindset

• Decision Making – demonstrates strong decision‑making by applying structured analysis to complex challenges, balancing competing priorities and long‑term impacts while engaging stakeholders and driving solutions aligned with organizational goals
• Collaboration and Team Building – promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and…