Philips Director, Clinical Affairs in Bothell, Washington
As the incumbent of this Clinical & Regulatory role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on Clinical evidence strategy, clinical plans development, regulatory approval/clearance, and regulatory compliance related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
Lead and manage a teams of Clinical Research professionals and Clinical Project Managers responsible for all Clinical Development activities in support of PH, Health & Wellness, M&C and Mobile Health business groups which has critical global evidence generation needs; lead and manage a team of regulatory professionals to provide regulatory support to those business groups.
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our Health focused company, you will be responsible for:
Successfully dealing with and managing Philips relationships with regulatory such as notified bodies & the US Federal Drug Administration (FDA).
Accountable for regulatory strategy, regulatory submission and day to day regulatory support to the responsible Business Groups
-Lead and ensure that all Clinical Research strategy & clinical Plans within the responsible Business Groups are developed and managed effectively in terms of:
Ensuring Clinical Development associates are integral and critical team members with strong understanding of all relevant aspects of the business (such as Medical, Regulatory, HEOR, R&D, Commercial) to enable development of appropriate clinical strategies
Ensure excellence in clinical trial design and project management in terms of timelines, quality/compliance and budget
Accountable for team's interface and collaboration with investigators, IRB's/EC’s, FDA, Competent Authorities/MoH, external CROsNendors, societies and associations, and company personnel
Act as a Subject Matter Expert in clinical trials involving complex design issues
Identify and assure strategies, resources and accountabilities are in place to achieve rapid, cost effective and well-executed clinical studies in the US and other countries
Be the subject matter expert in biologic pre-market safety reporting with thorough understanding of post market drug safety requirements
Ensuring strong scientific lead in the reporting and interpretation of results, including support for registration and dissemination of evidence in peer-reviewed journals
Responsible for global clinical development resource allocation
Responsible for global budgetary oversight and accountability
Ensure appropriate Talent Management, including:
Provide guidance and 'mentorship' for all direct reports
Ensure career development plans and succession plans are in place
Drive effective performance management
Work with VP Clinical and Regulatory to optimize organizational design/performance
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
The role reports solid line to the Head of Regulatory & Clinical Affairs, Group Q&R
We are looking for:
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
Specific skill requirements for this role include:
This position requires a Master’s degree, preferably in a life-scientific discipline, and a minimum of 10 years of experience working including Clinical and regulatory affairs within a global medical device industry, of which 7 years were in a leadership role.
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality, Clinical & Regulatory are right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
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, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In 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.