Director Clinical Operations

Cochlear•Lone Tree, CO

1d•$178,000 - $195,000•Hybrid

About The Position

Change people’s lives and love what you do at Cochlear—the most recognized brand in hearing health care—helping people hear and be heard around the world, while being part of one of Denver Business Journal’s 2026 Best Places to Work honorees in Denver. If you have experience leading clinical investigations and monitoring in the medical device/pharmaceutical industry and a passion for leadership, this is a fantastic opportunity to join the Clinical Operations team at the global leader in implantable hearing devices! In this role, you will be based in our Americas head office in Lone Tree, CO. The Director of Clinical Operations is responsible for developing and implementing the short- to medium-term clinical operations strategy for the region while managing the delivery of Cochlear Sponsored investigations. This role ensures clinical studies are delivered with regulatory excellence, operational efficiency, financial accountability, and alignment to business objectives and priorities. In this role, you will lead a team of Clinical Operations professionals, partner closely with regional stakeholders, sites, vendors, and cross-functional teams, and oversee the execution of complex, multi-site clinical investigations. You will be responsible for optimizing resources, strengthening operational capabilities, improving study delivery performance, managing regional vendor and site strategies, and using metrics and dashboards to drive continuous improvement in clinical research delivery. As a senior leader, you will also serve as a regional escalation point for complex operational challenges, support compliant study startup and site activation, oversee budgets and contracts, and help ensure readiness for audits, inspections, ethics committee interactions, and applicable regulatory requirements. This role requires deep clinical operations expertise, strong financial and analytical acumen, proven people leadership, and the ability to translate organizational strategy into effective regional execution.

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
Demonstrated 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%)

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) governing the conduct of clinical studies.
Serve as regional point of contact for regulatory inspections, audits, and ethics committee interactions