Director Clinical Strategy
Core
Lead clinical strategy and operational execution for a cannabinoid-based drug (Exilby) treating chronic pain, managing the full lifecycle from study design to regulatory submission.
Role type
Director, Clinical Strategy & Operations
Builds
Clinical study programs and regulatory dossiers for a novel pain therapy
Domain
Biopharma / Chronic Pain / Cannabinoid-based therapeutics
Required skills
Clinical study design, regulatory dossier preparation, team leadership (12+ members), vendor management, process optimization, strategic program planning, data quality oversight, patient safety management
Preferred skills
Experience in top-tier strategy consulting or dynamic startup environments, fluency in German and English
Technologies
Clinical trial management systems, statistical programming tools, regulatory submission platforms
Responsibilities
Oversee Medical Writing, Data Management, Biostatistics, Programming, Medical Monitoring, and Clinical Safety functions; Design clinical studies and define data requirements; Lead the clinical team and drive professional development; Manage external service providers and project budgets; Develop strategic direction for the clinical study program including new indication selection; Coordinate with regulatory authorities for approval submissions.
Seniority
Director, strategic leadership with hands-on operational responsibility
