Senior Director

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.
• 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.
• 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.

Preferred experience/background:

• 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.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our SVP, Development
• Some travel may be required – up to 20%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $217,500 - $304,500 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/25tarsusbenesnap.

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