Senior Clinical Development Scientist

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 innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’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 more. That’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

By building up the clinical expertise within Philips and creating impact through the development and testing of high-quality Philips’s products and solutions that help countless people worldwide.

You are responsible for

• Collecting, appraising, and analyzing clinical data pertaining to a (medical) product.

• Writing documentation, such as Clinical Evaluation Reports (CERs), and Post-Market clinical Follow-up reports (PMCF) supporting regulatory submission.

• Collaborating with internal (project owners, regulatory, study managers, statisticians, business leaders, post-market surveillance, risk management, Marketing, legal, etc.) and external (clinical consultants, subject matter experts, regulatory agencies, etc.) stakeholders to ensure comprehensive analysis of clinical evidence.

• Ensuring appropriate interpretation and dissemination of all evidence generated, including writing Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), Post-Market clinical Follow-up (PMCF) Reports, and supporting the timely publication of study results.

• Creating procedures and workflows related to the Clinical Development department. Review, assess, and revise document preparation procedures and SOPs regarding their efficiency, workflow, and implementation.

• Providing support for the operation of clinical trials and product approvals in the USA, EU and ROW

• Leading clinical risk assessment throughout – from ideation through Market introduction

• Development of evidence generation & dissemination strategies to support innovation projects

• Delivery of Clinical Development Plans requirements (i.e., EU, China)

You are a part of

The Philips Personal Health Clinical Affairs team. This team supports the Businesses Grooming and Beauty, Mother, and Child Care and Oral Health Care which develop both medical and non-medical products.

To succeed in this role, you’ll need a customer-first attitude and the following

• Preferable Masters or PhD degree in biomedical Science or Health-related field or M.D. with 3-5 years of experience in the medical device or Pharma industry or consumer electronics.

• Trained and experienced in medical writing; systematic review, and clinical data appraisal: MDR compliant CERs and PMCFs is a plus.

• A demonstrated working knowledge of GCP, ICH guidelines, ISO14155, FDA regulations and EU regulations

• Experience with research methodology (including clinical investigations design and biostatistics)

• Experience with clinical budgeting

• Proven track record of delivering clinical results, on time, within budget, and in compliance with SOPS and regulations

• Ability to collaborate effectively with various teams – clinical operations, engineering, cross-functional team members, as well as external partners

• Professional and proficient in reading, writing, and speaking English

How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We 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