Director Clinical 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. This role ensures clinical studies are delivered with regulatory excellence, operational efficiency, financial accountability, and alignment to business objectives and priorities.

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.
• Direct clear performance expectations across the region to drive operational excellence and career growth.
• 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).
• Serve as regional point of contact for regulatory inspections, audits, and ethics committee interactions.

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)
• 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
• Proven ability to innovate, deliver change and navigate ambiguity
• Understanding of quality systems, risk management, and regulatory compliance in the context of clinical research
• 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%)