In this role, you have the opportunity to
Work with a cutting edge product line - IGT Devices is part of the Philips Image Guided Therapy (IGT) business group. As the Senior Clinical Development Scientist, you will be responsible for developing and delivering evidence generation/dissemination strategies for multiple and/or complex projects; including, but not limited to, study design, scientific validity, data integrity, strategic guidance and reporting.
You are responsible for
Will provide strategic input into clinical aspects related to the end to end (E2E) Coronary, EP, Peripheral Vascular and Lead Management clinical development portfolio, from ideation through post marketed products
Work closely together with internal stakeholders (R&D project managers, regulatory affairs specialists, health care economic reimbursement specialists, clinical study managers, statisticians, business leaders, etc.) to ensure that the clinical safety and performance objectives will be met through non-clinical and clinical strategic input for product development and validation testing. Also work with external stakeholders (clinical consultants such as Key Thought Leaders (KTL’s) and subject matter experts (SME’s) to further depth of clinical knowledge, develop clinical strategies for current portfolio products as well as new products and advanced development projects of innovative technologies.
Responsible for professional collaboration with, investigators, IRB’s/EC’s, Regulatory Agencies, societies, and associations
Additional collaboration may occur to support claims, reimbursement, health economic outcomes and / or market access.
Through active cooperation with physicians and / or medical researchers, the clinical scientist will work with scientific writing personnel or take a leading role to support the publication of study results.
Will ensure appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer reviewed manuscripts, as assigned.
Will lead or support scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, including during sponsor regulatory inspections.
You are a part of
The Senior Clinical Development Scientist reports to the Director of Clinical Development. This position offers the opportunity to impact lives through the clinical trial development and testing of quality Philips products and solutions that help countless people all over the world. We have a fantastic work environment and culture that is respectful and rewarding, that offers opportunities to develop and grow both personally and professionally. These opportunities are limited only by one’s initiative and desire to succeed. The ability of this position to work with both internal and external customers promotes a broader vision to additional opportunities across Philips as a global company.
To succeed in this role, you should have the following skills and experience
Must have medical device industry experience
Scientific education (preferably Masters or PhD degree preferred in BioMedical Science or Health related field), with extensive experience in doing research for industry
Hands-on patient care experience as a healthcare provider is desirable
A demonstrated working knowledge of GCP, ICH guidelines, FDA regulations (21CFR812) and EU (ISO14155) regulations
Deep understanding of product development and associated design controls within the operational framework of a Quality Management System for medical devices.
Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology and operational experience is a must
8+ years of experience in a similar role in the Medical Device or Pharma industry
Excellent verbal and written communication skills (English); multiple languages is a plus
Ability to collaborate effectively with various teams - clinical operations, engineering, cross-functional team members, as well as external partners
Self-directed with a strong work ethic, with an ability to work in a goal-oriented environment
Strong writing skills to produce quality clinical documents, including final reports
Analytical thinking, able to present statistical methods and results to a variety of audiences, especially non-statisticians
Proficient computer skills across multiple applications (MS Office, with experience in and an aptitude for clinical trial software, proven ability to apply statistics into method development and sample analysis, experience with SAS/SPSS statistical software is a plus
Travel: Able to travel, including international (25% travel, or more at times)
In return, we offer you
We offer you the opportunity to grow within the organization and Philips – working cross functionally with R & D, on various projects and initiatives to drive our products to our customers and be a part of saving people’s lives every day.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
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As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.