Director Clinical Research Operations

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 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. 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 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 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. 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. Equal Employment Opportunity 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 View phone number on click.appcast.io. #J-18808-Ljbffr Cochlear