Senior Director, Pre-Clinical Science

Summary

Join Tarsus Pharmaceuticals as a Sr Director of Pre-Clinical Science and lead the non-clinical toxicology, PK, and bioanalysis functions. You will play a key role in developing and building the eye care pipeline, collaborating with the Innovation Lab and other departments to define clinical/translational strategies. Responsibilities include leading nonclinical toxicology/PK programs, interpreting data, authoring regulatory documents, and building relationships with CROs. You will also oversee preclinical protocols and reports, ensuring data quality and integrity. The ideal candidate will have a PhD in a relevant field with 15+ years of experience in the pharmaceutical industry, including ophthalmology product development. Strong leadership, communication, and regulatory knowledge are essential.

Requirements

• PhD degree in pharmacology, toxicology or related field with 15+ years’ experience in the pharmaceutical or industry setting
• Outstanding organizational and interpersonal skills, and outstanding ability to manage relationships and influence others
• Proven experience in designing non-GLP and GLP safety studies
• Demonstrated ability to work closely with CROs and provide close oversight of vendors, budget planning and coordination
• Hands on experience in relevant laboratory techniques
• Willingness to be both a strategic leader and hands-on problem solver
• Experience allocating resources and managing budgets
• Proven knowledge of FDA regulations
• Superior oral and written communication skills are required, and the ability to work effectively with senior management. Strong analytical and scientific writing skills
• Strong creativity, independent thinking and results orientation is required
• Must have high ethical standards and impeccable integrity
• Strong people leadership abilities, including inspiring and motivating a high performing team, setting clear direction, enabling cross-functional collaboration, empowering people, and developing and coaching talent
• Ability to understand stakeholder concerns and frame issues/proposals to influence decision making

Responsibilities

• Collaborate with key experts across the company including Clinical Development, Regulatory Affairs, CMC and Innovation lab to appropriately advise on non-clinical strategy for early POC trials as well as to appropriately meet global regulatory requirements
• Establish key relationships with consultants and CROs to conduct the studies
• Build non-clinical functional capabilities with a hybrid model of internal and external resources that is scalable
• Collaborate with Innovation Lab and BD (on due diligences) to develop integrated Safety Assessment, Toxicology and PK program strategies
• Lead the conduct, interpretation and reporting of Toxicology, PK and other relevant non—clinical studies/data
• Critically evaluate toxicology results and provide strategic guidance to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy
• Develop experimental strategy to understand the mechanisms of toxicity as needed
• Responsible for the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, BLA, briefing books, Investigator brochures, etc.)
• Interface with regulatory agencies as required
• Responsible for the preparation of data summaries and presentations of results to internal and external stakeholders, as required
• Responsible for building and maintaining effective CRO and consultant relationships that support the execution of non-GLP and GLP toxicology/biodistribution studies
• Review study protocols and draft study reports, providing feedback as needed and responsible for report finalization
• Develop and implement SOPs to guide functional activities. Oversee the development of the nonclinical regulatory strategy, design of experiments, interpretation of data and oral and written presentation of results
• Oversee the review and approval of all preclinical protocols and final reports for nonclinical development studies and ensure data quality and integrity for preclinical sites
• Effectively communicate preclinical findings to project teams, senior management, regulators and other external partners
• Provide technical support to various departments within the company with respect to safety assessment, PK and toxicology
• Due diligence
• Bring scientific expertise to due diligence in collaboration with BD team, identify main risks and mitigation plan in their area of expertise
• Build open relationships with peers and external partners to ensure best decision making
• Clearly identify risks and mitigation plans. Ensures team contribution to clinical and regulatory development plan

Preferred Qualifications

• Experience in ophthalmology product development and understanding ocular safety risk is highly desired
• Superior knowledge and understanding of emerging research, mechanisms of action and disease models in anterior and posterior segment eye care diseases, preclinically and clinically is desired
• Knowledge of the clinical landscape in ophthalmology indications with good understanding of novel agents and impact to this landscape
• Superior interpersonal skills, diplomacy, and positive-influencing abilities
• Leadership ability to drive decision-making within a multi-disciplinary, matrix teams
• Scientifically independent
• Enterprise and entrepreneurial mindset
• Track record of success and measurable contribution in moving ophthalmology therapeutic programs forward through preclinical and/or clinical development in an academic or industry setting
• Experience in research and/or development of anterior and/or posterior eye care segment therapies

Benefits

• Health, dental and vision insurance benefits
• Paid time off, including vacation, holidays, and personal days
• Bonus
• Stock equity
• Comprehensive benefits
• Hybrid work environment
• Remote work is an option