TRITON AI is an innovative biopharmaceutical leader dedicated to developing life-saving vaccines and oncology therapeutics. They are seeking an experienced Global Clinical Project Lead to drive clinical trial execution across various regions, ensuring effective collaboration with cross-functional teams throughout the clinical trial process.
Responsibilities:
- End-to-End Project Leadership: Manage regional operational strategy, timelines, budgets, and risk mitigation for Phase I-IV clinical trials across SEA (Singapore, Malaysia, Thailand, Indonesia, Vietnam, Philippines), North Asia, North America and Latin America
- Site Excellence: Oversee site selection, initiation, monitoring, and close-out activities, ensuring compliance with ICH-GCP and local regulations
- Vendor Partnership: Lead CROs, central labs, and regional vendors to deliver quality data on schedule
- Stakeholder Engagement: Serve as primary point of contact for investigators, internal teams (Medical, Regulatory, Data Management), and country managers
- Risk Management: Proactively identify and resolve operational challenges across diverse regulatory environments
- Resource Stewardship: Manage regional budgets up to $[X]M and mentor junior CRAs
Requirements:
- 5+ years in clinical operations with 2+ years direct project management experience leading multi-country trials
- Demonstrated vaccine clinical trial experience (prophylactic vaccines required; COVID, influenza, RSV, etc.)
- Proven success managing studies in Southeast Asia, US and other regions; familiarity with country-specific regulatory landscapes
- Mastery of ICH-GCP, clinical trial management systems (CTMS), and risk-based monitoring
- Bachelor's degree in Life Sciences (Advanced degree preferred)
- Business fluency in English; Chinese as a working language is an advantage
- Advanced degree preferred