Philips Clinical Development Scientist in Bothell, Washington
Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Distinguished by additional specialized knowledge in
breadth and/or depth, as well as record of success in relevant business process/function.
Has expert level knowledge of company products and services and may be tasked with introducing new concepts.
Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
This position is responsible for managing a part of a business process or function.
Manages activities of two or more sections or departments.
Exercises supervision in terms of costs, methods, and staffing.
In some instances this manager may have subordinate supervisors.
Primary duty is managing individual contributors or managing two or more sections or departments.
In this role, you have the opportunity to:
Develop clinical strategies and processes that have global impact across multiple Business Groups within Philips, and ensure that our innovative HealthTech products are launched on time, on budget, and with best-in-class clinical evidence.
You are responsible for
Providing support for the strategy and design of clinical trials to support Philips Business Groups, with a focus on the Ultrasound Business Group.
Providing support for developing processes, workflows, documentation, and training to ensure compliance with US, EU, China, and other geographies’ regulatory requirements.
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, EU MDR).
Keeping current with regulatory guidance and requirements in the global environment.
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 advanced degree in Biomedical Science or Health related field).
A demonstrated working knowledge of GCP, FDA regulations and EU regulations.
Deep understanding of regulatory clinical requirements, such as the EU Medical Device Regulation.
10 years of experience in a similar role in the Medical Device or Pharma industry.
Ability to collaborate effectively with various teams - clinical operations, engineering, cross-functional team members, as well as external partners.
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.
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. Learn more by watching this video .
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/philips-recruitment-process.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 or der 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.