Sr Director, Pre-Clinical Science

About the Role

The Sr Director role will head Pre-Clinical Science function and will be an important leader in helping to develop and build the eye care pipeline at Tarsus. They will be responsible for bringing the non-clinical toxicology, PK and bioanalysis expertise in defining the clinical/translational strategy for pipeline projects. The role starts with strong partnership with our Innovation Lab function and continues through the program development with key focus on safety/PK risk assessment and meeting regulatory requirements for approval.

As a nonclinical subject matter expert, the Sr Director will be responsible for the overall strategy and execution of the nonclinical toxicology/PK program, collaborating cross-functionally with project leads, providing data interpretation at various internal venues, and authoring regulatory documents.

Let’s talk about some of the key responsibilities of the role:

• 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.

MAIN RESPONSIBILITIES

• 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.

Factors for Success:

Minimum Requirements/Qualifications:

• PhD degree in pharmacology, toxicology or related field with 15+ years’ experience in the pharmaceutical or industry setting.
• Experience in ophthalmology product development and understanding ocular safety risk is highly desired.
• 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.
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