Senior Director, Clinical Development

Summary

Join our team as a Sr. Director, Clinical Development to lead the development of clinical strategies and oversee clinical research activities.

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