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
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

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

PhD, MD/PhD, DVM, or related field in Toxicology, Pharmacology, Biology; DABT or ERT certification preferred.
12+ years in pharma or biopharma toxicology/pathology.
Knowledge of GLP and ICH guidance; Experience with EMA/FDA CTA/IND submissions and regulatory interactions is a plus.
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.
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 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.