Executive Medical Director, Immunology Clinical Development - Gastroenterology
Core
Leads the design, implementation, and interpretation of clinical development programs for immunology/gastroenterology molecules, ensuring study integrity and generating data to support product strategy.
Role type
Executive Medical Director, Clinical Development
Builds
Clinical development plans, protocols, Investigator Brochures, Clinical Study Reports, and regulatory submissions for immunology/gastroenterology assets.
Domain
Pharmaceutical industry, Immunology, Gastroenterology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial methodology, regulatory and compliance requirements, clinical strategy development, study protocol design, safety and efficacy data interpretation, cross-functional team leadership, Good Clinical Practices (GCP), pharmacovigilance standards.
Preferred skills
Subspecialty fellowship experience, complex program independent leadership, external opinion leader interaction.
Technologies
Clinical trial management systems, regulatory submission platforms.
Responsibilities
Lead and own the design and implementation of multiple clinical development programs; oversee project-related education of investigators and study staff; review and interpret accumulating safety and efficacy data; ensure study enrollment and timelines; assess and report serious adverse events; lead the development of Clinical Development Plans; serve as clinical representative for regulatory discussions; ensure adherence to GCP and quality standards.
Seniority
Executive, strategic leadership with hands-on program ownership