Director Clinical Research Operations

About the role

The Director of Clinical Operations leads regional clinical operations strategy and study execution for Cochlear-sponsored investigations. They oversee high-quality, compliant clinical research delivery across multiple countries and regulatory jurisdictions. They drive operational excellence, resource optimization, vendor strategy, site performance, and continuous improvement across the region.

Responsibilities

• Develop and implement the Clinical Operations strategy for study execution in the region, ensuring studies are executed on-time and within budget.
• Serve as the escalation point for complex operational challenges affecting the region, working collaboratively with Regional peers and team members to develop and implement solutions.
• Drive operational efficiency initiatives across regional clinical operations, identifying opportunities to standardize processes, leverage technology, optimize vendor relationships, and reduce waste.
• Ensure the Regional Clinical Operations team adheres to specific study protocols and complies with established regional and country-specific clinical research standards (including ISO 14155:2011 and 2020, ICH-GCP, MDR, IVDR, and applicable national regulations).
• Direct clear performance expectations across the region to drive operational excellence and career growth.
• Oversee budgets and contracts, and help ensure readiness for audits, inspections, ethics committee interactions, and applicable regulatory requirements.

Requirements

• Bachelor's Degree in Scientific or Health-related Discipline
• 8-10 years' of progressive experience in clinical operations within the pharmaceutical or medical device industries, with at least 3 years in leadership roles
• Proven experience managing clinical operations across multiple countries and regulatory jurisdictions
• Deep knowledge of ISO 14155:2011 and 2020, ICH-GCP, and applicable regional regulations (e.g., FDA 21 CFR 812, MDR/IVDR, country-specific requirements across APAC)
• Extensive experience with region-specific clinical research challenges (e.g., ethics committee processes, reimbursement landscapes, healthcare system structures)
• Proven track record of planning and executing complex, multi-site, clinical investigations
• Extensive experience with region-specific clinical research challenges (e.g., ethics committee processes, reimbursement landscapes, healthcare system structures)
• Experience in people management and development, with demonstrated success building and leading high-performing teams
• Demonstrated ability to translate organizational strategy and context into operational execution
• Financial acumen including budget development, financial management, and resource optimisation
• Demonstrated ability to innovate, deliver change and navigate ambiguity
• Understanding of quality systems, risk management, and regulatory compliance in the context of clinical research
• Proven ability to partner effectively with cross-functional stakeholders including Regulatory Affairs, Quality, Commercial, and external partners
• Cultural intelligence and ability to work effectively across diverse organizational and cultural contexts
• Strong analytical skills with ability to leverage data and metrics to drive decision-making and continuous improvement
• Fluency in English; additional language skills highly valued
• Willingness and ability to travel internationally (approximately 20%)