Head of Medical, Clinical, & HEOR – Connected Care
- United States of America – Home Based
- Full time
Head Medical, Clinical & Heor
In this role, you will build Medical, Clinical Affairs & HEOR capabilities with critical competencies to meet current and future evidence needs for the Connected Care business while ensuring development of clinical evidence strategies, driving innovation and delivering evidence of value to clinical and non-clinical partners for new products / solutions and existing products.
You are responsible for
- Lead the creation/integration of the Medical and Clinical Affairs, and HEOR org designed to develop the critical capabilities to meet the business needs.
- Develop key clinical evidence strategies to drive innovation, and deliver evidence of value to clinical and non-clinical stakeholders.
- Develop talent to effectively overseeing all Medical and Clinical Affairs, and HEOR operational processes End2End and throughout the product/software/service/systems lifecycle.
- Lead and drive effective deployment of the Philips Excellence Process Framework and Quality Management Systems.
- End to end Clinical Affairs including Clinical Development and Operations as well as Medical Affairs.
- Lead business Medical and Clinical Affairs, and HEOR teams on applicable regulations, requirements, and standards through the development of clinical plans and evidence strategies.
- Develop submission strategy for new products/solutions
- Plan, generate, manage and coordinate clinical evidence generation to support submissions for product/solution licensing.
- Lead Medical and Clinical Affairs, and HEOR programs to ensure the highest level of compliance, effectiveness and efficiency.
- Partners with the market Medical and Clinical Affairs, and HEOR teams to build and maintain all the critical relations with respective regulators in the applicable Clinical Care businesses.
- Partners with the Philips Government Affairs and the Global Regulations & Standards team to align Medical and Clinical Affairs, and HEOR activities and representation of Philips in the necessary industry associations
- Strategic role at RACA leadership team building future medical & clinical org capability
- Pro-actively advise and counsel the Head of RACA, Q&R Group by providing analysis and interpretation of medical and clinical issues, KPI’s and requirements as well as consequences of these on the effectiveness of the QMS, business and budget. This includes the necessary Medical and Clinical Affairs, and HEOR input to the management review process.
- Support the relevant organizations with inspections conducted by agency investigators and directs the formal response to any findings.
You are a part of
Connected Care 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.
Connected Care builds on our existing strengths, bringing together monitoring and therapeutic devices, software and services to create smart solutions to deliver on the quadruple aim of value-based healthcare. The Connected Care Business cluster is comprised of: Monitoring & Analytics, Population Health Management, Sleep & Respiratory Care, Therapeutic Care & Connected Care Informatics.
This role reports solid line to the Head of Regulatory, Medical, & Clinical Affairs, Group Q&R. Dotted Line to the CEO, Clinical Care Businesses.
To succeed, you should have the following skills and experience
- Proven leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to maximize product market access.
- Understanding the diverse worldwide medical device regulations and clinical evidence requirements, the experience to know how to successfully apply those regulations in an efficient, effective and compliant manner.
- Proven experience in understanding consequences of new and changing regulations to Clinical Care businesses and effectively and pro-actively transferring this knowledge and understanding to all applicable stakeholders to ensure timely compliance with these regulations and guaranteeing continuous market access.
- An ability to successfully lead virtual teams of Medical and Clinical Affairs, and HEOR professionals existing of both direct and functional reports in order to effectively and efficiently execute pre-market approval and post-market surveillance processes.
- Proven experience in successfully representing organizations in industry associations.
- The experience to lead and develop strategies for a multi-site, global healthcare business while also being able to design and execute specific projects and lead teams.
- This position requires a Master’s degree, preferably in a life-scientific discipline, and a minimum of 15 years of experience working in Medical and Clinical Affairs within a global medical device industry, of which 7 years were in a senior leadership role.
- Extensive knowledge of MDD, Medical Devices, FDA QSR’s, ISO 13485 & 14155, and other for the market EMEA applicable regulations.
- Experience with Research and Development, Sales and Service, Manufacturing, Marketing, IT, Document and Data Management, Purchasing/Procurement, Logistics and Service/Installation.
- An advanced degree in management is strongly preferred.
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.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.