Associate Principal Scientist, Clinical Research

Role: Early Clinical Scientist (ECS) providing operational and scientific leadership for early-phase vaccine clinical trials within Translational Medicine. Responsibilities include designing, planning, and executing clinical pharmacology strategies from first-in-human to late-stage development, ensuring compliance with GCP, ICH, and regulatory standards, and managing cross-functional team performance. The ECS oversees study safety, risk management, data interpretation, and may participate in study monitoring and site training. They author key clinical and regulatory documents, develop study protocols and SOPs, and lead project management efforts for trial execution. The role involves representing early development initiatives internally and externally, mentoring junior staff, and contributing to scientific publications and presentations. Qualifications require a life sciences degree with ≥11 years experience (or equivalent), with at least 6 years in Phase 1 or 8 years in Phase 2-3 clinical trials, specifically in vaccine programs. Essential skills include clinical trial management, scientific and regulatory writing, GCP/ICH knowledge, and cross-functional collaboration. Preferred qualifications include an advanced degree, experience with global Phase 1 trials, safety reporting, and NDA/WMA submissions. The position is hybrid, with approximately 10% travel, based in the US, and offers a competitive salary and benefits package.