Executive Medical Director, Gastroenterology, Early R&I Clinical Development
Core
Lead clinical development for gastroenterology and immunology pipeline assets, shaping early phase programs and therapeutic area strategy.
Role type
Executive Medical Director (Early R&I Clinical Development)
Builds
Clinical development plans, protocols, and study designs for small molecules, monoclonal antibodies, and oligonucleotides.
Domain
Biopharmaceuticals, Gastroenterology, Immunology
Required skills
Clinical development leadership, therapeutic area strategy, cross-functional team management, regulatory compliance (FDA/MHRA/ICH GCP), clinical trial design, medical monitoring, stakeholder engagement, project management, data-driven decision making, biostatistics principles.
Preferred skills
Experience with in-licensing opportunities, qualification of pharmacodynamic/disease markers.
Technologies
None stated
Responsibilities
Design, delivery, and interpretation of clinical studies ensuring ethical and scientific integrity; Provide medical strategy and clinical expertise to cross-functional teams; Follow medical developments and disseminate new information to transform trends into agile clinical plans; Collaborate across early and late R&I clinical development to ensure high-quality plan delivery; Represent clinical development to external stakeholders including investigators and advocacy groups; Lead regulatory communication and preparation of higher level documents; Ensure peer review of study/program design; Support qualification of biomarkers for early efficacy assessment; Provide clinical strategic input to in-licensing opportunities.
Seniority
Executive, Strategy & Mentorship