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Tarsus Pharmaceuticals

Develops FDA-approved ophthalmic therapies

Director, Toxicology Translational Science

Biology & BiotechConfirmed live in the last 24 hours
Full-timeIrvine, CA, USA

About the Job

Requirements

  • A PhD, MD/PhD, or DVM in Toxicology, Pharmacology, Biology, or a related field is required; DABT or ERT certification is preferred.
  • At least 12 years of experience in pharma or biopharma toxicology or pathology.
  • Knowledge of Good Laboratory Practice (GLP) and International Council for Harmonisation (ICH) guidance.
  • Experience managing outsourced studies.
  • Experience with EMA/FDA CTA/IND submissions and regulatory interactions is a plus.
  • Strong oral and written communication skills, including writing, reviewing, and editing scientific documents.
  • Strong interpersonal, diplomacy, and positive-influencing abilities.
  • Effective project management skills.
  • Strong presentation skills and the ability to provide succinct, strategic, and actionable insights.
  • Ability to lead work independently, anticipate issues, and take a proactive approach.
  • Ability to make structured decisions on complex challenges, balance competing priorities and long-term impacts, engage stakeholders, and drive solutions aligned with organizational goals.
  • Ability to align diverse teams around shared goals, foster constructive debate, and build networks that strengthen cross-team learning.
  • Ability to align teams around shared priorities, address risks and dependencies, and drive cross-functional accountability to deliver results.
  • Ability to use financial and strategic insight to guide investments, manage risk, and align priorities with long-term organizational value.
  • Ability to champion new ideas, invest in enabling systems and partnerships, and translate innovation into sustainable growth and organizational resilience.

Responsibilities

  • Serve as a scientific and strategic leader driving team and pipeline development, using toxicology, safety pharmacology, and translational science to bridge discovery and clinical development from concept through IND-enabling and early clinical studies.
  • Serve as a subject matter expert in toxicology, safety pharmacology, and nonclinical safety assessment across Tarsus programs.
  • Establish and maintain external partnerships with contract research organizations, academic institutions, and key opinion leaders.
  • Define and drive GLP safety and toxicology strategies across programs to accelerate programs to first-in-human studies.
  • Oversee GLP and non-GLP toxicology and safety pharmacology studies at contract research organizations, ensuring scientific rigor, data integrity, regulatory compliance, standard operating procedures, and technical study requirements.
  • Review and edit study protocols and reports to ensure scientific rigor, regulatory compliance, and high-quality study interpretation.
  • Author and review toxicology sections for regulatory submissions, including IND, CTA, NDA/BLA, investigator brochures, and clinical study reports.
  • Represent toxicology in cross-functional program teams and governance forums.
  • Maintain study timelines and ensure nonclinical studies are conducted in accordance with overall program objectives.
  • Partner with internal experts, including the Innovation Lab and Business Development, on asset evaluation and development strategies; identify toxicology risks and mitigation strategies.
  • Identify and implement innovative artificial intelligence-driven toxicology approaches, including new approach methodologies, to support regulatory submissions and interactions with regulatory agencies.

Desired Qualifications

  • DABT or ERT certification.
  • Experience with EMA/FDA CTA/IND submissions and regulatory interactions.

About the Company

Tarsus Pharmaceuticals

Develops FDA-approved ophthalmic therapies

Tarsus Pharmaceuticals develops and markets treatments for eye care and infectious diseases, including XDEMVY (lotilaner ophthalmic solution 0.25%), an FDA-approved eye drop for Demodex Blepharitis. The product is applied as a medicated eye drop to kill Demodex mites and relieve eyelid inflammation. The company differentiates itself with a focused ocular/infectious-disease portfolio, an FDA-approved therapy, and active partnerships to expand its research and reach. Its goal is to address unmet medical needs, grow its product lineup through commercialization, and pursue new indications in eye care and infectious diseases.

Company size
201-500
Company stage
IPO
Headquarters
Irvine, CA
Founded
2017

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