Director of Clinical Operations

About the role

The Director of Clinical Operations, Image Guided Therapy Devices, oversees day-to-day clinical program operations, ensuring progress against goals while leading complex negotiations with regulatory bodies, sites, and vendors and streamlining operations through innovative methodologies. This role partners with executive leadership and cross-functional teams across IT, Clinical/Medical, Regulatory, Legal, Quality, Procurement, and Finance to shape large-scale research strategy, analyze industry trends, advise stakeholders, manage vendors and deliverables as Product Owner, and provide clear reporting to senior leadership and regulatory authorities.

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

Required:

• Acquired 10+ years of directly related clinical research or clinical operations experience, preferably within the medical device industry, including 5+ years leading or managing clinical operations teams.
• 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; an advanced scientific, clinical, regulatory, public health, or business degree is preferred.
• Experience with cardiovascular, peripheral vascular, coronary, electrophysiology, structural heart, image guided therapy, catheter-based technologies, global clinical trial execution, and digital clinical trial systems is highly desirable.
• Able to supervise exempt and non-exempt employees, oversee vendors and external partners, support hiring and performance management decisions, and travel domestically and internationally approximately 20–30% of the time.
• Ability to perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Qualifications

Preferred:

• Experience with Philips products and services.
• Leadership experience in a fast-paced, dynamic environment.
• Strong communication and interpersonal skills.
• Knowledge of regulatory affairs and clinical trial processes.
• Experience with project management tools and methodologies.
• Experience with clinical trial data management systems.
• Experience with clinical trial monitoring and auditing.
• Experience with clinical trial site management and recruitment.
• Experience with clinical trial data analysis and reporting.
• Experience with clinical trial quality assurance and compliance.
• Experience with clinical trial budgeting and financial management.
• Experience with clinical trial regulatory submissions and approvals.
• Experience with clinical trial data security and privacy.
• Experience with clinical trial stakeholder engagement and communication.
• Experience with clinical trial data integrity and accuracy.
• Experience with clinical trial data validation and verification.
• Experience with clinical trial data reconciliation and consolidation.
• Experience with clinical trial data storage and retrieval.
• Experience with clinical trial data visualization and reporting.
• Experience with clinical trial data analytics and modeling.
• Experience with clinical trial data mining and extraction.
• Experience with clinical trial data cleaning and preprocessing.
• Experience with clinical trial data transformation and normalization.
• Experience with clinical trial data integration and interoperability.
• Experience with clinical trial data governance and stewardship.
• Experience with clinical trial data sharing and collaboration.
• Experience with clinical trial data protection and confidentiality.
• Experience with clinical trial data security and privacy.
• Experience with clinical trial data quality and reliability.
• Experience with clinical trial data accuracy and precision.
• Experience with clinical trial data completeness and consistency.
• Experience with clinical trial data timeliness and efficiency.
• Experience with clinical trial data relevance and applicability.
• Experience with clinical trial data representativeness and validity.
• Experience with clinical trial data generalizability and extrapolation.
• Experience with clinical trial data reproducibility and replicability.
• Experience with clinical trial data transparency and openness.
• Experience with clinical trial data accessibility and usability.
• Experience with clinical trial data availability and sustainability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.
• Experience with clinical trial data longevity and durability.