[Hiring] Clinical Project Lead - Vaccines @Fuku

Role Description

This role involves leading pivotal vaccine trials across diverse Southeast Asian markets.

• Enjoy the flexibility to be based in either Singapore/Malaysia/Vietnam/the Philippines/China.
• Ensure regional study delivery from initiation to close-out.
• Collaborate with cross-functional teams to advance our portfolio in infectious diseases.

Key Responsibilities

• End-to-End Project Leadership: Manage regional operational strategy, timelines, budgets, and risk mitigation for Phase II-IV vaccine trials across Southeast Asia (Singapore, Malaysia, Thailand, Indonesia, Vietnam, Philippines).
• 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.

Qualifications

• Experience: 5+ years in clinical operations with 2+ years direct project management experience leading multi-country trials.
• Therapeutic Expertise: Demonstrated vaccine clinical trial experience (prophylactic vaccines required; COVID, influenza, RSV, etc.).
• Progression Path: Senior/Lead CRA or CRA II ready for project leadership with documented increasing responsibility.
• Regional Knowledge: Proven success managing studies in Southeast Asia; familiarity with country-specific regulatory landscapes.
• Technical Skills: Mastery of ICH-GCP, clinical trial management systems (CTMS), and risk-based monitoring.
• Education: Bachelor’s degree in Life Sciences (Advanced degree preferred).
• Language: Business fluency in English; Chinese as a working language is an advantage.