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.

Let’s talk about some of the key responsibilities of the role:

• 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, ensure 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
• Authoring and review of 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

Internal and External Innovation:

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

Factors for Success:

Minimum Requirements/Qualifications:

• 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 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.

Tarsus Competencies:

• 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 cross-team learning.
• Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
• Business Acumen - Demonstrates strong business acumen by anticipating market dynamics and using financial and strategic insight to guide investments, manage risk, and align priorities with long-term organizational value.
• Innovative Mindset and Action - Demonstrates an innovative mindset by championing new ideas, investing in enabling systems and partnerships,