Clinical Affairs Director

Clinical Affairs Director

Job Description

As Director of Clinical Affairs – MRI, you will lead the development and execution of clinical strategies that support regulatory submissions, clinical validation, and market adoption of cutting-edge MRI technologies. You will spearhead the generation of high-quality evidence, including for AI-enabled imaging features, ensuring that Philips remains at the forefront of clinical innovation and compliance in the evolving global MedTech landscape. This role is pivotal in aligning with regulatory standards like ISO 14155, EU MDR, and the EU AI Act, and in driving lifecycle-integrated clinical development across our MRI portfolio.

Your role:

• Lead the design, execution, and delivery of global clinical evidence strategies across the MRI portfolio, including AI-integrated technologies.
• Collaborate closely with cross-functional teams including Regulatory Affairs, R&D, and Medical Safety to support end-to-end product lifecycle activities, from early feasibility to post-market evidence generation.
• Serve as subject matter expert on international clinical and AI-related regulatory requirements (FDA 510(k), NMPA, EU MDR, EU AI Act), ensuring early integration of these requirements in project plans.
• Lead a multidisciplinary global team of up to 10 direct reports, spanning clinical operations, data science, and biostatistics, to successfully execute comprehensive studies and trials.
• Engage with regulatory bodies (e.g., via FDA Q-Subs), KOLs, and academic partners to align study protocols and support claim substantiation.
• Drive the Annual Operating Plan (AOP) for MRI Clinical Affairs, ensuring efficient budget utilization, resource alignment, and quality deliverables.
• Champion a culture of GCP compliance and audit readiness across all study activities.
• Oversee timely updates to Clinical Evaluation Reports (CERs), PMCF activities, and AI-specific clinical documentation.
• Represent Clinical Affairs/ Medical Office within the MRI Business Unit leadership, contributing to innovation strategy and risk/benefit assessments.

You're the right fit if:

• You hold a Medical Degree (M.D) or another healthcare-related university degree like Biomedical Sciences, Medical Biology, e.g.
• You have 10+ years of clinical experience with radiology systems in a hospital or 10+ years of experience in clinical development within the MedTech, MedDev, including strong exposure to imaging modalities or AI-enabled devices.
• Proven leadership experience (6+ years) managing clinical research and operations teams across multiple regions.
• Deep knowledge of GCP, ISO 14155, MDR/IVDR, and AI/ML-specific regulations (FDA, EU AI Act).
• Build and maintain strong professional networks while acting as a trusted advisor to stakeholders at all levels, demonstrating a change management mindset to navigate, adapt to, and lead through organizational transformations effectively.
• Ability to work effectively in a matrixed, global organization with a solution-oriented and quality-focused mindset.

How we work together
We believe that we are better together than apart. For this office-based teams, it means working in-person at least 3 days per week.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion.