Global Clinical Program Lead, Immunology
Core
Lead late-stage clinical development for small molecules, biologics, or cell therapies in gastroenterology and immunology, ensuring patient safety and regulatory compliance.
Role type
Senior IC clinical program lead (gastroenterology/immunology)
Builds
Clinical study protocols, development plans, and regulatory documentation for Phase IIb-IV trials
Domain
Pharma / Clinical Immunology / Gastroenterology
Required skills
Medical degree (MD/MD-PhD), specialist training in gastroenterology or clinical immunology, leading Phase 2-4 clinical trials, biostatistics knowledge, global regulatory environment expertise, pharmacovigilance experience, study design, clinical development planning, Target Product Profile definition
Preferred skills
Experience leading clinical programs to support indication approval, fast-learning curve for new disease areas
Technologies
Clinical trial management systems, statistical analysis software, regulatory submission platforms
Responsibilities
Drive clinical and scientific decisions within Global Study Teams, ensure patient safety and GCP compliance, author study documents (protocols, SAPs, ICFs), manage safety surveillance and AE reporting, review Clinical Study Reports, lead governance interactions (DRACs, DRCs), manage line of project study physicians and scientists, present at international investigator meetings
Seniority
Senior, hands-on IC with line management responsibilities