Senior Director Clinical Operation

IntelliPro; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

A leading clinical trials organization in Singapore is seeking a seasoned professional to oversee global Phase I-III multicentre trials. This role involves managing local clinical operations teams, ensuring compliance with international standards, and building strategic partnerships with key stakeholders. Ideal candidates will have 13+ years of clinical operations experience and a Master's degree. Proficiency in English and Chinese is required for effective cross-cultural communication.

Qualifications

• 13+ years of clinical operations experience in pharmaceutical or biotechnology companies.
• Experience managing full-cycle Phase I-III global clinical trials.
• Knowledge of local clinical research environment and regulatory landscape.

Responsibilities

• Oversee end-to-end execution of global multicentre trials across regions.
• Manage regional clinical operations teams for trial quality and compliance.
• Build and maintain strategic relationships with KOLs and clinical sites.

Skills

Clinical trial management

Project management

Fluent in English and Chinese

Leadership skills

Cross-cultural communication

Education

Master's degree or higher in Clinical Medicine, Pharmacy, Biology, or a related field

Job description

Responsibilities

• Oversee end-to-end execution of Phase I–III global multicentre trials (MRCTs) across regions including China, US, Europe.
• Manage regional clinical operations teams and ensure trial quality, timelines, and compliance with CFDI, FDA, EMA, and ICH-GCP standards.
• Serve as the primary point for regulatory inspection readiness (CFDI/FDA/EMA) and response.
• Build and maintain strategic relationships with KOLs, clinical sites, and CROs in key regions, especially the US and Europe.
• Collaborate with global cross-functional teams to align regional execution with worldwide development strategy.

Qualifications

• Master's degree or higher in Clinical Medicine, Pharmacy, Biology, or a related field.
• 13+ years of clinical operations experience, including at least 8 years focused on clinical trial management, with experience in pharmaceutical or biotechnology companies.
• Proven experience in managing full-cycle Phase I-III global clinical trials, including hands-on experience in international MRCT project management, and having led at least one project from initiation through regulatory submission.
• Experience in designing and executing Non-Oncology Phase III clinical trials, with familiarity with clinical development pathways and regulatory requirements in relevant therapeutic areas.
• Understanding of the local clinical research environment, site operations, and healthcare policy/regulatory landscape.
• Strong leadership skills with the ability to effectively manage local teams and collaborate across cultures and time zones.
• Fluent in both English and Chinese, with proficiency in using both as working languages, and capable of cross-cultural communication and coordination.