Global Clinical Program Lead, Immunology

Role: Global Clinical Program Lead in Immunology, focusing on late-stage development of small molecules, biologics, or cell therapies for gastroenterology indications. Primary objectives include overseeing clinical development plans, study design, medical monitoring, and ensuring compliance with GCP, to advance immunology assets through phases IIb to IV. Responsibilities encompass providing scientific medical input, leading global study teams, managing safety surveillance, contributing to study reports, and supporting regulatory and investigator interactions. Leadership duties involve stakeholder engagement, governance interactions, co-leading publication strategies, and line management of study physicians and scientists. Requirements: MD or MD-PhD with at least 5 years’ industry experience, specialized in gastroenterology or clinical immunology, with a proven track record in leading or reviewing clinical trials supporting drug approval (Phases 2-4). Knowledge of biostatistics, regulatory environment, and pharmacovigilance is essential. Preferred: experience in clinical development plan creation, Target Product Profile, and cross-functional collaboration. High-Value: emphasis on immunology, gastroenterology, late-phase (IIb-IV), regulatory interactions, and global study leadership. Location: hybrid work model with in-person presence preferred, with unspecified travel expectations.