Director of Clinical Operations

About This Role

This role oversees the day-to-day clinical program operations for Image Guided Therapy Devices, ensuring progress towards goals while leading complex negotiations with regulatory bodies, sites, and vendors. The Director streamlines operations through innovative methodologies and partners with executive leadership and cross-functional teams to shape large-scale research strategy and manage vendors.

Responsibilities

• Lead the operational planning and execution of clinical trials and evidence generation programs across Coronary, Peripheral, and Cardiac Solutions, including early feasibility, pivotal, pre-market, post-market, registry, real-world evidence, and investigator-initiated or company-sponsored studies
• Translate clinical evidence strategies and protocols into executable plans covering timelines, enrollment, site activation, monitoring, vendors, budgets, resourcing, and risk mitigation
• Oversee end-to-end study startup and execution, including site feasibility, investigator selection, contract and budget coordination, ethics committee and IRB submissions, site initiation, patient enrollment, monitoring, data collection, protocol compliance, deviation management, adverse event workflows, documentation, and closeout
• Ensure all clinical studies are inspection ready and executed in accordance with ICH GCP, ISO standards, FDA and global regulatory requirements, local country requirements, and Philips quality and compliance policies
• Partner with Regulatory, Quality, and Clinical Affairs to support regulatory submissions, clinical evaluations, annual reports, post-market surveillance needs, and timely delivery of high-quality evidence outputs
• Manage clinical operations governance, vendor oversight, and performance management across CROs, core and imaging laboratories, data management partners, safety vendors, electronic data capture providers, and other external study partners
• Establish operating rhythms for study team meetings, enrollment reviews, budget reviews, milestone tracking, risk escalation, and senior leadership updates
• Build, lead, and develop a high-performing Clinical Operations team with clear goals, accountability, execution discipline, collaboration, and continuous improvement
• Represent Clinical Operations in governance forums, core team meetings, product development discussions, senior management reviews, and external discussions with investigators, vendors, and regulatory authorities as needed

Requirements

• 10+ years of directly related clinical research or clinical operations experience, preferably within the medical device industry
• 5+ years leading or managing clinical operations teams
• Demonstrated track record of delivering complex clinical studies on time, within budget, and in compliance with applicable requirements
• Deep knowledge of clinical trial execution across the product lifecycle, including study startup, site activation, enrollment, monitoring, vendor management, data collection, closeout, inspection readiness, budgets, contracts, timelines, site performance, vendor deliverables, and operational risk
• Expertise in ICH GCP, ISO 14155, FDA medical device regulations, informed consent, adverse event reporting, protocol deviation management, clinical trial documentation, trial master file expectations, and global regulatory and operational requirements
• Bachelor’s degree in a scientific, clinical, health sciences, engineering, or related discipline

Nice to have:

• Advanced scientific, clinical, regulatory, public health, or business degree
• Experience with cardiovascular, peripheral vascular, coronary, electrophysiology, structural heart, image guided therapy, catheter-based technologies, global clinical trial execution, and digital clinical trial systems

About the Company

This company is involved in Image Guided Therapy Devices.