Clinical Project Lead - Vaccines

Title: Clinical Project Lead - Vaccines - Fuku

URL Source: https://apply.workable.com/j/1A7A448849

Markdown Content: Job Title: Clinical Project Lead - Vaccines

Location: Singapore/Malaysia/Vietnam/the Philippines/China (Remote)

Reports To: Head, Global Clinical Operations

Employment Type: Full-Time

About Us

We are an innovative biopharmaceutical leader dedicated to developing life-saving vaccines and therapeutics. As we expand our global footprint, we seek an experienced Clinical Project Manager to drive clinical trial execution across Southeast Asia and support our international growth ambitions.

The Opportunity

• Lead 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.

Required 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.