Philips Senior Clinical Development Scientist 

United States, District of Columbia, Washington 

781270473

Senior Clinical Development Scientist (Bothell, WA)

The Senior Clinical Development Scientist for the Ultrasound group will be responsible for developing, generating, and disseminating clinical and economic evidence ensuring innovation, and transformation with best-in-class clinical evidence.

Your role:

• Contribute strategic guidance for clinical and economic evidence related to the end to end (E2E) development process from ideation through post-market for products in the Ultrasound business.
• Collaborate with key internal and external stakeholders to provide in-depth expertise to develop and lead clinical initiatives through non-clinical and clinical strategies for new product development initiatives and product life cycle management.
• Drive execution ensuring quality and timeliness of clinical programs and/or trials to support critical regulatory requirements, be agile and responsive during course of design, execution, and interpretation of trial data.
• Collaborate with investigators, IRB’s/EC’s, Regulatory Agencies, societies, and associations; and additionally, to support claims, reimbursement, health economic outcomes and/or market access.
• Participated in clinical evaluation documentation including guidance on Post Market Clinical Follow Up (PMCF) initiatives and clinical investigation documents in accordance with applicable regulatory standards.
• Ensure appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, as assigned.
• Lead or support scientific discussions with regulatory agencies or notified bodies, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, in line extensions, including during sponsor regulatory inspections.

You are the right fit if:

• You have acquired 7+ years of experience in clinical research/development/real world evidence (RWE); strong scientific background and experience with Artificial Intelligence algorithm clinical performance validation. You have deep expertise including innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics.
• Your skills include a demonstrated working knowledge of GCP, FDA regulations and EU-MDR regulations, and in-depth understanding of product development and associated design controls for medical devices. You have strong writing skills to product quality clinical documents, including final reports. Strong knowledge and experience with study design is also desired. You are experienced in creation of CEPs, CERs, PMCFPS, and PMCF documentation. You have an ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications.
• You have a medical or scientific education (MD or PhD).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You are self-directed with a strong work ethic, agile, and have an ability to work in a purposeful environment. You can collaborate effectively and influence decision making with various teams cross-functionally, as well as externally. You can think analytically, present statistical methods and results to a variety of audiences, especially non-statisticians. You can travel up to 15% (domestic and international) according to business needs.

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

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If you are interested in this role and have many, but not all, of the experience 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 .

The pay range for this position in Bothell, WA is $144,900 to $231,840 annually.

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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

be provided for this position. For this position, you must reside in