Philips Senior Clinical Development Scientist in Eindhoven, Netherlands

Your challenge

Reporting to the Philips Handheld Medical Director, the senior Clinical Development Scientist is responsible for clinical activities to support product development and life-cycle management within Philips Handheld Diagnostics platforms, with collaborative relationships with all relevant and cross-functional partners (e.g. R&D, Marketing, Clinical Affairs, Regulatory Affairs, etc), ensuring cross-functional alignment. He/she is also responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations, Biostatistics and Data Management teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP), and to ensure appropriate interpretation and dissemination of all evidence generated including CSRs, abstracts, manuscripts, etc

The senior Clinical Development Scientist will lead clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections, and is responsible for team’s interface and collaboration with key opinion leaders.

Your responsibilities

• Provides strategic and scientific clinical research leadership to support product registration(s) and life-cycle through development of innovative evidence generation strategies

• Deliver excellence in clinical trial design, leading development of clinical documentation

• Leads project management in terms of timelines, quality/compliance and budget

• Comprehensive understanding of clinical trial regulations across multiple regions

• Collaborate across different functional areas within Clinical Affairs (Clin Ops, Biostatistics, Data Mgt) to ensure alignment with business objectives

• Build collaborative relationships with key internal and external partners and stakeholders, including regulatory agencies, CROs, Scientific Advisory Boards, etc

• Act as a Subject Matter Expert in clinical trials involving moderately complex design issues

• Create strategies to achieve rapid, cost­ effective and well-executed clinical studies across multiple regions

• Ensure strong scientific lead in the reporting and interpretation of results, including support for registration and dissemination of evidence in peer-reviewed journals

Your team

Philips Handheld Diagnostics (HHDx) has developed the Minicare system, an easy-to-use handheld point-of-care testing platform which aims to bring lab equivalent performance at the patient bedside. The HHDx business unit operates in the Point of Care market space, which can be defined as the place where blood testing is taking place close to the patient. The Point of Care market is around $5.4 billion and growing at 6%. Cardiac point of care is a significant segment at around $680 million and growing at 9%.The first focus of the business unit is to launch two important Cardiac Markers (cardiac Troponin-I and BNP) on the Minicare system. Product, production processes and organization are built from scratch. Aim is to generate new business in a new market which will significantly contribute to the growth ambitions of Philips.

Our offer

We welcome you to a challenging, innovative environment with great opportunities for you to explore.

Our benefits are very competitive and designed around your preferences:

• 25 Days of leave and the possibility to purchase up to 20 extra days off annually

• A variable bonus based on both Philips results and personal performance

• Extensive set of tools to drive your career, such as a personal development budget, free training and coaching

• Solid company pension scheme and attractive collective health insurance package

• Opportunity to buy Philips shares and products with discount

• Healthy work-life balance

We are looking for

M.D., Ph.D. or M.S. in Biology, Pharmacy or closely scientific related discipline. Equivalent education or experience will be considered.

Experience & Background

• 6+ years related scientific / technical experience, including 3+ years role within Clinical Research in In-vitro Diagnostics or Medical Device

• Experience in delivering clinical programs within clinical research setting, on time, within budget and in compliance to SOPs and regulations;

• Comprehensive understanding of clinical trial regulations across multiple regions

• Ability to deliver critical milestones

• Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders

• Leadership requirement – ability to influence, shape and lead without direct reporting authority

• Experience in effective management of project budget processes

• Experience in medical and scientific writing

• Excellent oral and written communication skills (English) are necessary

• Experience with working in an international environment is recommended

• Medical background and international network in IVD or Medical Device

• Experience in emergency medicine and point-of-care testing is a plus