Director, Toxicology

Director, Toxicology

Irvine, California, United States

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, and translating innovation into sustainable growth and organizational resilience.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our VP, Translational Science
• Some travel may be required – up to 20%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $188,200 - $263,600 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days.