Clinical Project Lead - Vaccines at Fuku

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

29 May, 26

Salary

0.0

Posted On

28 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Leadership, Clinical Operations, Vaccine Trials, ICH-GCP Compliance, Risk Management, Vendor Management, CRO Management, Budget Management, Site Selection, Stakeholder Engagement, CTMS Mastery, Risk-Based Monitoring, Regulatory Knowledge, Data Management, Infectious Diseases, English Fluency

Industry

Retail Apparel and Fashion

Description

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.

Responsibilities

The role involves end-to-end leadership for regional operational strategy, timelines, budgets, and risk mitigation for Phase II-IV vaccine trials across Southeast Asia. Responsibilities also include overseeing site excellence, managing vendors like CROs, and serving as the primary contact for investigators and internal teams.