Write and review relevant content of key clinical and regulatory documents including protocols, investigator brochures (IBs), informed consent forms (ICFs), clinical study reports (CSRs), safety updates, annual reports, BLA/CTA submission materials, and responses to Health Authorities. Lead the design, execution, interpretation, and reporting of clinical trials across assigned programs, including study endpoints, biomarkers, imaging strategies, sample size considerations, patient enrollment approaches, timelines, and governance interactions.