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Job type full-time
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Job title
Senior clinical development scientist
Job description
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovationDriven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we areWe are 80,000, wonderfully unique individuals, with two things in commonAn unwavering sense of purpose and a relentless determination to deliver on our customers’ needsIt’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do moreThat’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today philips’ purpose has never been more relevantSo whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
You are responsible for
Providing support for the strategy and design of clinical trials, investigator-initiated studies, and other forms of clinical and economic evidence, with a focus on the ultrasound business.
Collaborating with product management team to ensure our product claims are quantifiable, customer-focused, and substantiated with world-class evidence,
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 and medical affairsThis 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.
To succeed in this role, you’ll need a customer-first attitude and the following
A medical or scientific education (preferably advanced degree: md and/or phd).
A demonstrated working knowledge of gcp, fda regulations and eu-mdr regulations.
Deep understanding of regulatory clinical requirements, such as the eu medical device regulation.
12+ years of experience in a similar role in the medical device preferred, would consider pharma industry experience in addition to medical device.
Ability to collaborate effectively with various teams – product management, clinical operations, engineering, program management, 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.
Us work authorization is a precondition of employmentThe company will not consider candidates who require sponsorship for a work-authorized visa.
In return, we offer you
The ability to collaborate with, learn and grow from colleagues in a highly complex, global organization where you can use your strengths to help drive strategic business initiatives for philipsAdditionally, we provide you a dynamic working environment in an innovative business, paired with a competitive salary, excellent benefits, and a supportive atmosphere where you can sharpen your talents with new challenges and career opportunities.
How we work at philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customersWe are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: there`s a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: choosing where, when and how to work can vary according to task and team schedulesFlexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: the way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
Why should you join philips?
Working at philips is more than a jobIt’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutionsHelp us improve the health and well-being of billions of people, every yearUltimately creating a career that no one could have planned forEven you.
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It is the policy of philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, philips is committed to a diverse workforceIn 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.
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