Remote Director, Clinical Development

Summary

Join our team as a Sr. Director, Clinical Development to lead the development and management of clinical development strategies, planning timelines and budgets for clinical programs while collaborating with cross-functional teams.

Requirements

• Advanced degree(s) in relevant field: PharmD, MD or MD/PhD
• Deep clinical expertise in Ophthalmology and a minimum of 15 years professional pharmaceutical clinical development experience
• 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

Responsibilities

• 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
• 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

Benefits

• Health, dental and vision insurance benefits
• Generous paid time off, including vacation, holidays, and personal days