Lead the Clinical Affairs team in the cluster Precision Diagnosis (PD).
Our customers are working in a changing healthcare world passionate about adding value to the life of their patients. They are looking for propositions that enable them to deliver excellent and high-quality care, that are easy to use and take burden away from the healthcare professionals and are worth their price. They require from Philips proven proof that our products and solutions cater for that need: show me you know and understand me, make it easy for me and be a partner I can rely on.Youareresponsiblefor
Responsible for developing talent to help drive execution of the operational processes End2End and throughout the entire lifecycle.
Develop and integrate key clinical evidence strategies in innovation
Deliver evidence of value to clinical and non-clinical partners.
Develop submission strategy for new products/solutions Plan, generate, lead and coordinate clinical evidence generation to support submissions for product/solution licensing.
Lead Clinical Affairs programs to ensure the highest level of compliance, effectiveness and efficiency.
Provide leadership in developing talent with critical proficiencies in robust scientific thinking to meet current and future clinical evidence challenges.
Lead the Clinical Affairs team on clinical investigation notifications / approval requests to applicable authorities.
Partner with the Governmental Affairs, Global Regulations & Standards team, and clinical team to align Clinical Affairs.
The Precision Diagnosis Business Cluster seamlessly connects patients, caregivers and ultimately consumers both inside and outside the hospital, enabling true networks of care. To realize measurable outcomes, we must move from siloed 'workstation' thinking to 'workflow' solutions.
This position requires a Master’s degree, preferably in a life-scientific field.
Minimum 10 years of experience working in Clinical Affairs within a global medical device industry, of which 7 years were in a senior leadership role.
Shown knowledge of MDD, MedDev’s, FDA QSR’s, ISO 13485 & 14155, and other for the market EMEA applicable regulations.
Shown leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to improve product market access.
Tried experience in understanding consequences of new and changing regulations to PD products and solutions and business groups and effectively and pro-actively transferring this knowledge and understanding to all applicable partners to ensure timely compliance with these regulations and guaranteeing continuous market access.
An ability to lead virtual teams of professionals existing of both direct and functional reports in order to effectively and efficiently execute pre-market approval and post-market surveillance processes.
Confirmed experience in representing organizations in industry associations.
Lead and develop strategies for a multi-site, global healthcare business while also being able to craft and execute specific projects and lead teams.
In return, we offer you
A path towards your most rewarding career. Succeeding in this role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
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.
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, and protected veteran or marital status.