Director, Toxicology

Tarsus Pharmaceuticals•Irvine, CA

15h•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

DABT or ERT certification preferred.
preference for individual with experience in ophthalmology.
Experience with EMA/FDA CTA/IND submissions and regulatory interactions preferred.

Responsibilities

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
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