Director, Toxicology
$188,200–$263,600 year
HybridIrvine, California, United States
Job Summary
Lead toxicology and safety pharmacology strategies across all Tarsus programs, establishing external partnerships with CROs and academic institutions to drive GLP and non-GLP studies. Define safety approaches to accelerate programs to first-in-human, overseeing study protocols, reports, and regulatory submissions including IND, CTA, and NDA/BLA. Build the Toxicology program and Bio-analytics capacity while representing the function in cross-functional teams and governance forums. Implement innovative AI-driven toxicology approaches and NAMs to support regulatory interactions. This role requires a PhD or MD/PhD with 12+ years in pharma toxicology, based in the Irvine office with up to 20% travel. The position reports directly to the VP, Translational Science, with a hybrid work environment.
Required Qualifications
- PhD, MD/PhD, DVM, or related field in Toxicology, Pharmacology, Biology
- 12+ years in pharma or biopharma toxicology/pathology
- Strong GLP and ICH guidance knowledge
- Experience with EMA/FDA CTA/IND submissions and regulatory interactions
- 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
- 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
- Must be based in our beautiful Irvine office
- Hybrid work environment
- Remote work is an option
- Some travel may be required – up to 20%
Desired Qualifications
- DABT or ERT certification preferred
- Preference for individual with experience in ophthalmology
- Experience with EMA/FDA CTA/IND submissions and regulatory interactions preferred
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