Director, Clinical Affairs – Coronary​/Vascular

• Develop and lead the global Clinical Affairs strategy across the coronary and vascular portfolio
• Align clinical evidence generation plans with product development, regulatory, commercial, health economics, and business objectives
• Partner with Marketing, Regulatory, Quality, R&D, Medical Affairs, and executive leadership to establish priorities and drive cross-functional alignment
• Architect and oversee clinical evidence programs across the product lifecycle, including early feasibility, pivotal, pre-market, post-market, registry, and real-world evidence studies
• Direct study design, protocol development, endpoint selection, statistical strategy, operational execution, and evidence dissemination
• Build and deliver clinical evidence and scientific communications supporting regulatory submissions, market registrations, clinical evaluations, product claims, publications, lifecycle management, and global evidence dissemination
• Ensure clinical programs are scientifically rigorous, operationally effective, and compliant with regulations, standards, and company policies
• Provide strategic clinical leadership throughout product development and commercialization
• Contribute clinical input to risk management, design controls, preclinical and clinical study strategies, new product development, and design history documentation
• Represent Clinical Affairs in governance forums, core teams, and business decision-making activities
• Lead and develop a high-performing Clinical Affairs organization
• Serve as the primary external clinical interface with regulatory authorities, investigators, key opinion leaders, professional societies, and scientific stakeholders
• Oversee team performance, budgets, timelines, and quality objectives
• Represent the business and Clinical Affairs function in senior leadership, regulatory, and external scientific engagements
• Travel domestically and internationally approximately 20–30% of the time

• 10+ years of directly related clinical or scientific experience
• Leadership or management experience within the medical device industry
• 5+ years managing a clinical research functional team
• Proven track record delivering complex clinical programs on time, within budget, and in compliance with applicable requirements
• Experience with coronary clinical research is required
• Comprehensive knowledge of clinical research regulations across multiple regions
• Knowledge of FDA medical device regulations
• Knowledge of medical device clinical trial practices
• Knowledge of Good Clinical Practice
• Knowledge of informed consent requirements
• Knowledge of regulatory documentation
• Knowledge of clinical evidence requirements supporting regulatory, product development, and commercial objectives
• Bachelor’s degree in a scientific discipline
• Ability to build strong internal and external relationships and influence through direct and indirect reporting lines
• Ability to communicate effectively with technical, clinical, regulatory, executive, and external audiences
• Ability to manage multiple studies, team priorities, and company initiatives in a complex matrixed environment
• Ability to represent Philips professionally in scientific, regulatory, clinical, and business forums
• US work authorization required; candidates requiring current or future visa sponsorship will not be considered
• Must reside in or within commuting distance to a posted location
• Ability to meet minimum physical, cognitive, and environmental job requirements with or without accommodation

Demonstrates extensive expertise in Clinical Affairs strategy, clinical evidence generation, and regulatory compliance within the medical device industry. Proven ability to lead cross-functional teams and manage complex clinical programs effectively.

• Clinical Affairs Strategy Development
• Coronary Clinical Research Management
• Regulatory Compliance Knowledge
• Clinical Evidence Generation
• Leadership in Clinical Research

• Clinical Research Regulations
• FDA Medical Device Regulations
• Good Clinical Practice
• Clinical Trial Practices
• Statistical Strategy
• Protocol Development
• Evidence Dissemination
• Operational Execution
• Risk Management
• Design History Documentation

• Effective Communication
• Relationship Building
• Influencing Skills
• Team Management
• Cross-Functional Collaboration

• Medical Device Industry
• Clinical Evidence Requirements
• Informed Consent Requirements
• Regulatory Documentation
• Product Development
• Market Registrations
• Clinical Evaluations
• Global Evidence Dissemination
• Executive Leadership Engagement
• Complex Matrixed Environment