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Director Clinical Operations Position Spotlight:

Lead regional clinical operations strategy and study execution for Cochlear Sponsored investigations Oversee high-quality, compliant clinical research delivery across multiple countries and regulatory jurisdictions Drive operational excellence, resource optimization, vendor strategy, site performance, and continuous improvement across the region Serve as a senior clinical operations leader responsible for people leadership, budget accountability, inspection readiness, and regional stakeholder partnership Hybrid work model of 3 days in office reporting to our North American headquarters in Lone Tree, CO Willing to travel up to 20% regionally and internationally About the role 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. Key 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 Key Requirements To add value to Cochlear in this role you'll be able to meet and demonstrate the following knowledge, skills and abilities in your application and at interview: 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%) Total Rewards In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits. Pay Range in the

United States:

$178,000 - $195,000 based upon experience, as well as an annual bonus opportunity of 20% of base salary. Exact compensation may vary based on skills, experience, and location. Benefit package includes medical, dental, vision, life and disability insurance as well as 401(K) matching with immediate vesting, Paid Time Off, tuition reimbursement, maternity and paternity leave, Employee Stock Purchase Plan and pet insurance. Who are we? Human needs have always been our inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant because he saw his father struggle with hearing loss. We always start with people in mind - thinking about their needs. For this reason, our products, services and support will continue to evolve and improve. We are by our customers' side through the entire hearing journey, so they can experience a life full of hearing. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people's lives and working in an organization where they can be part of bringing the mission to life each day. Physical & Mental Demands The physical and mental demands described below are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is regularly required to be in a stationary (seated/standing) position; utilize business technology for work product delivery, communicate orally and in writing with others internal or external to the organization, utilize problem solving/critical thinking skills to discern and convey information. May be asked to occasionally transport/move up to 30 pounds, depending on the position. Specific vision abilities required by this job include ability to adjust focus. The individual is regularly required to utilize comprehension, critical thinking, communication, problem solving, organization reasoning, relating to others and discernment of items such as product specifications, procedures and processes to customers (whether internal or external). Influence, organization/classification of information and planning are also required. The work environment is a home/office. This is representative of the environment an individual may encounter while performing the essential functions of this job. Apply now by completing your application form online. Applicants must meet the job specific application criteria to be considered. Visit our careers site at www.cochlear.us/careers to learn more. Cochlear Americas is an Equal Opportunity Employer. We will provide reasonable accommodations for qualified individuals with disabilities. If you require accommodation with completing the online application, please contact us via web or phone at 303-264-2549.

Application deadline:

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Find & Apply For Clinical Research Manager Jobs in Lone Tree, Colorado

Director Clinical Research Operations