Senior Director, Clinical Scientist
Core
Leading scientific strategy and execution for clinical trials targeting metabolic dysfunction-associated steatohepatitis (MASH) and liver diseases.
Role type
Senior Director, Clinical Scientist
Builds
Clinical trial protocols, study designs, and regulatory submissions for MASH therapeutics
Domain
Biopharmaceuticals, Liver disease, Metabolic disorders
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical development strategy, Clinical trial design, Protocol development, Regulatory submission preparation, Data interpretation, Cross-functional collaboration, Therapeutic area expertise (MASH/NASH), ICH/GCP regulations
Preferred skills
Liver disease endpoints (histology, imaging, biomarkers), Regulatory interaction experience, Fast-paced biotech environment experience
Technologies
Clinical trial management systems, Statistical analysis software, Regulatory submission platforms
Responsibilities
Design and develop clinical trial protocols including scientific rationale and endpoints; Author or review key clinical documents such as investigator brochures and clinical study reports; Provide scientific input during trial execution and site engagement; Collaborate with clinical operations, data management, and biostatistics to ensure data integrity; Conduct data reviews and support interpretation; Support preparation of documents for regulatory submissions and health authority meetings; Stay current on therapeutic area trends and regulatory guidance.
Seniority
Senior Director, strategic leadership & cross-functional alignment
