Associate Principal Scientist, Clinical Research

Role: Early Clinical Scientist (ECS) leading operational and scientific aspects of vaccine early-phase clinical trials within Translational Medicine, supporting the translation of scientific discoveries into human proof-of-concept. Responsibilities: oversee trial design, planning, and execution; ensure GCP, ICH, and regulatory compliance; manage safety assessment, risk mitigation, and data interpretation; author critical clinical and regulatory documents; lead cross-functional teams and develop SOPs; mentor junior staff and represent clinical initiatives externally. Requirements: Bachelor's in Life Sciences, 8+ years of related experience, with at least 6 years in Phase 1 or 8+ years in Phase 2-3 clinical trials; expertise in vaccine clinical programs, clinical trial management, scientific writing, and regulatory guidelines. Preferred: advanced degrees, experience with global Phase 1 trials, safety reporting, and NDA/WMA submissions. High-Value: vaccine modality, early-stage development (FIH to proof-of-biology), cross-functional leadership, GxP compliance, regulatory interaction, and global trial oversight. WorkSetup: hybrid; travel ~10%.