Executive Director, Clinical Scientist
Core
Leading scientific strategy and execution of clinical trials for MASH therapeutics, specifically Rezdiffra, to advance assets toward regulatory milestones.
Role type
Executive Director, Clinical Scientist (Strategic IC)
Builds
Clinical trial protocols, regulatory submissions, and data interpretation for MASH/NASH programs.
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 authoring, Regulatory submission support, Data interpretation, Cross-functional leadership
Preferred skills
Liver disease therapeutic area expertise, Histology/imaging endpoint knowledge, Regulatory interaction experience
Technologies
ICH/GCP guidelines, Clinical trial management systems
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 including site engagement and data reviews; Collaborate with clinical operations, biostatistics, and medical writing to ensure data integrity; Support preparation of documents for regulatory submissions and health authority meetings; Stay current on therapeutic area trends and regulatory guidance for MASH/NASH.
Seniority
Executive Director, strategic leadership