Senior Clinical Development Scientist

Join Philips as a Senior Clinical Development Scientist, where you have the opportunity to make a significant impact by building clinical expertise and contributing to the development of high-quality medical products. As a key member of the Philips Personal Health Clinical Affairs team, you will collaborate with internal and external stakeholders to ensure comprehensive analysis of clinical evidence. This role involves leading clinical risk assessments, acting as a clinical investigator in trials, and supporting product approvals globally.

Your Role:

• As a Senior Clinical Development Scientist at Philips, you will play a crucial role in collecting, appraising, and analyzing clinical data for medical products, contributing to regulatory submissions.

• Collaborate with diverse internal and external stakeholders, including project owners, regulatory bodies, statisticians, and clinical consultants, to ensure thorough analysis of clinical evidence.

• Lead clinical risk assessments, act as a clinical investigator in trials, and support product approvals globally, from ideation through market introduction.

• Develop evidence generation and dissemination strategies, ensuring compliance with GCP, ICH guidelines, ISO14155, FDA regulations, and EU regulations.

• Write documentation, such as Clinical Evaluation Reports (CERs), and Post-Market clinical Follow-up reports (PMCF) supporting regulatory submission.

• Create procedures and workflows related to the Clinical Development department. Review, assess, and revise document preparation procedures and SOPs regarding their efficiency, workflow, and implementation.

• Delivery of Clinical Development Plans requirements (, EU, China)

You're the Right Fit If:

• You have a PhD in biomedical science or a health-related field with 7-10 years of experience in the medical device, pharma, or consumer electronics industry.
• Demonstrated proficiency in medical writing, systematic review, and clinical data appraisal; experience with MDR compliant CERs and PMCFs is a plus.
• Working knowledge of GCP, ICH guidelines, ISO14155, FDA regulations, and EU regulations; experience in research methodology, clinical investigations design, and biostatistics.

Proven track record of delivering clinical results, ability to collaborate effectively with cross-functional teams, and professional proficiency in English

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 here