Medical Director, Global Clinical Program Leader - Immunology
Core
Lead scientific expert and clinical program leader for pre-clinical and early-stage immunology assets, driving Clinical Development Plans (CDP) and ensuring GCP/ICH compliance.
Role type
Senior IC Medical Director / Global Clinical Program Leader
Builds
Clinical Development Plans (CDP), Study Outlines, Investigator Brochures, Clinical Study Protocols, and regulatory submission packages for immunology therapies.
Domain
Biotechnology / Immunology / Clinical Development
Required skills
Clinical program leadership, CDP development, regulatory submission authorship, cross-functional stakeholder management, risk mitigation, medical writing, clinical data analysis, strategic target product profiling.
Preferred skills
Board certification in relevant field, extensive pharmaceutical/biotech industry experience, matrix environment leadership.
Technologies
GCP, ICH regulations, Clinical Development Plan (CDP), Investigator Brochure (IB), Clinical Study Protocol (CSP), Master Informed Consent Form (ICF), Clinical Study Report (CSR), IND, NDA, BLA.
Responsibilities
Lead cross-functional Clinical Development Teams (CDT) and serve as clinical representative on due diligence teams; Develop and maintain Clinical Development Plans (CDP) and Target Product Profiles (TPP); Author key study documents and regulatory interaction packages; Ensure clinical and scientific standards across all program aspects; Drive decision-making and issue resolution within the CDT.
Seniority
Senior, hands-on IC
