In this role, you have the opportunity to
Develop clinical strategies that have global impact across multiple Business Groups, and ensure that our innovative HealthTech products are launched on time, on budget, and with best-in-class clinical evidence. The Clinical Development Scientist will work as part of a cross-functional team to develop and deliver clinical strategies to support a portfolio of products, from the earliest stage of development through post-market surveillance. This includes, but is not limited to, study design, scientific validity, data integrity, strategic guidance and reporting.
You are responsible for
Providing support for the strategy and design of clinical trials in the USA, EU and ROW.
Working closely together with internal (project owners, regulatory, clinical study managers, statisticians, business leaders, etc.) and external (clinical consultants such as key opinion leaders and subject matter experts) stakeholders to ensure that studies yield well-founded conclusions.
Collaborating with, investigators, IRB’s/EC’s, Regulatory Agencies, etc., to support claims, reimbursement, health economic outcomes and / or market access.
Developing study protocols in compliance with project standards and specifications and regulatory guidelines (GCP, ICH, FDA, ISO).
Keeping current with regulatory guidance and requirements in the global environment.
Writing study reports and assisting with preparing submissions to applicable regulatory authorities.
Ensuring appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, etc.
You are a part of
The Clinical Development Scientist reports to the Director of Clinical Affairs. This position offers the opportunity to impact lives through the 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, and offers opportunities to develop and grow both personally and professionally.
To succeed in this role, you should have the following skills and experience
Scientific education (preferably Masters or PhD degree preferred in Biomedical Science or Health related field).
A demonstrated working knowledge of GCP, ICH guidelines, FDA regulations and EU regulations.
Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology and operational experience is a must.
10 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, proven ability to apply statistics into method development and sample analysis; experience with statistical software is a plus.
In return, we offer you
We believe that every growth period creates an exceptional career runway. In fact, the Clinical and Scientific Affairs leadership team gets out of bed every morning with the sole focus of growing the business and growing the people who contribute to it. Luckily, you are the benefactor of this unique opportunity and leadership commitment- likely to experience an exciting high stakes, mobility-focused environment from which to create your own future – personally, professionally & financially.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.