Sr Director, Clinical Development

About the Role

The Sr. Director, Clinical Development will be a leader responsible for development, management, oversight of the clinical development strategy, planning development timelines and budgets for the clinical programs while collaborating closely with clinical operations and other cross functional teams such as CMC, Quality, Regulatory, Med Affairs, Project Management, Finance and Legal. A primary focus for this position will be to design novel, innovative early development POC trials that requires out of the box thinking and execution. This person will develop the global clinical plans, program outlines, study designs and clinical study essential documents as needed. This individual will be accountable for leading the cross-functional Study Teams to meet study deliverables and represent clinical development in core team, executive team, and investigator meetings as needed. This person will work closely with the business development team and will be involved in clinical due diligence. The Sr. Director will also contribute to departmental policies and SOPs as well as projects and staffing plans. 

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

• Provides leadership, scientific and strategic planning, direction, and implementation of clinical development activities.
• Provides clinical leadership and disease area expertise into integrated disease area strategies.
• Partners closely with KOLs in specific indications.
• Evaluates strategic options against a given Target Product Profile (TPP)
• Establishes clinical strategies and designs clinical trial protocols that can rapidly and robustly assess proof-of-concept in early trials as well as designing late stage trials. Ability to develop a range of clinical strategy options, makes recommendations, and facilitates decision making.
• Leads the clinical science team and oversees the strategy, planning, and resourcing of clinical research activities and clinical trials.
• Leads and oversees the training of study investigators on protocol and on clinical trial procedures.
• Authors CSRs, SAPs, Protocols, Clinical Value dossiers, IBs, DSURs, ICFs etc.
• Leads the analysis and interpretation of clinical data to inform strategic decision-making, identifying trends, and ensure data insights communicated effectively.
• Conducts research to develop foundational educational material to inform the program strategies.
• Provides leadership and strategic oversight in the determination of study objectives, strategy, scope, and schedule to meet business needs; align the team on common priorities and initiatives.
• Partners across functional lines with clinical operations, regulatory affairs, clinical pharmacology, statistics, project management, preclinical science, and others as needed.
• Serves as program lead on Core teams, investigator meetings, and scientific advisory boards.
• Ensures the leadership team is kept informed of study progress and that all critical issues are appropriately escalated within the organization.
• Define and negotiating the scope of work (SOW), budget, pricing, and payment schedules for the clinical vendors.
• Leads innovation by identifying and integrating cutting-edge technologies and methodologies into clinical trial design.   

Factors for Success:

• Advanced degree(s) in relevant field: PharmD, MD or MD/PhD and deep clinical expertise in Ophthalmology and a minimum of 15 years professional pharmaceutical clinical development experience, with a minimum of10 years leadership in clinical trial management experience required.
• Extensive experience in early clinical development of ophthalmology and understanding of working in a smaller company, with nimble and innovative mindset.
• Experienced in industry with expertise in the areas of clinical trial design and execution, and strategic planning; experienced with early to late stage clinical trials, and with the IND to NDA process.
• External focus to understand the trends in the disease area, treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of Tarsus.
• Established leadership track record with evidence of excellent performance-based people management experience, problem solving, collaboration, cross functional leadership and effective communication skills.
• Positive communication style, with a can-do attitude and strong work ethic.
• Organized with a systematic approach to prioritization.
• Ability to work collaboratively to project plan, problem solve and deliver results.
• Expertise with SOPs, GCPs and regulatory and compliance guidelines for clinical trials.
• Significant knowledge of clinical and outcomes research study design.
• Proficient knowledge of medical terminology and clinical research industry.

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 VP, Clinical Development
• Domestic and international travel may be required up to 50%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $247,500 - $346,500 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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