Philips Associate Director Clinical Development in United States of America - Home Based, Massachusetts
If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
Support product development, innovation and currently marketed products by driving the evidence generation strategy and plans in the assigned business unit. Serving as the core team medical lead, you will work with as a member of a cross functional team and represent the current clinical, medical and scientific thinking as it pertains to evidence generation approaches that will ensure Philips products demonstrate differentiated value. Additionally, you will support Philips’ transition into the EU MDR regulated environment by ensuring that our devices are compliant to global regulations, in order to prevent business disruption in any market. You will partner with key regulatory, commercial, R&D, professionals to drive consistently good clinical practices within Philips, contributing to seamless regulatory approvals.
You are responsible for:
Leads development of evidence generation strategies of assigned clinical studies, working within a business unit cross-functional team
Supporting the software Electronic Medical Records team; experience with software as a medical device is preferred
Serve as the core team medical and scientific partner in product development teams
Create the subsequent clinical evaluation plans
Develop strong collaboration with KOLs and Investigators
Deliver assigned clinical studies, working in partnership with Clin Ops & BSDM
Participate in the interpretation & dissemination of evidence generated from clinical evaluation plans such as CSRs and CERs
Support clinical evidence discussions with regulators, advisory boards, associations and societies
Provide clinical compliance guidance to drive global initiatives such as EU MDR
Write clinical evaluation plans, reports, PMCF studies, and clinical investigation documents in accordance with the clinical evaluation process and applicable regulatory standards (EU MDR, MEDDEV and ISO)
Assist in the review and creation of clinical related procedures to assess their adherence to applicable regulatory standards and corporate goals.
Determine and support the implementation of process improvements and resolution of issues
Member of a cross functional team responsible for determining clinical strategy
Provide clinical insight into product specifications
Provide input for Design Output/ program deliverables throughout product life cycle.
Provide input into design risk management documents and post market health hazard evaluations (HHE)
Support product usability compliance activities by providing clinical input
Review and assess potential non-conformance and work with stakeholders for CAPA resolution
Provide support during certification audits and regulatory inspections
Communicate strategy and compliance activities to internal stakeholders
Maintain clinical compliance files and tracking databases as required
Communicate with regulatory agencies as needed
You are a part of: As part of the EMR (Electronic Medical Records) & CM (Care Management) team we leverage advanced technology and deep clinical and consumer insights, delivering integrated solutions to improve people’s health and enable better outcomes across the health continuum. This exciting opportunity is supporting Philips’ transition into the EU MDR regulated environment as well as the clinical development needs of the business. This position works in partnership with R&D, marketing, regulatory, quality, and legal among other functional areas. To succeed in this role, you should have the following skills and experience
Deep understanding in global clinical evidence requirements, including regulatory paths
Experience supporting Software as a Medical Device
Subject matter expertise in relevant domain (technology / therapeutic area)
Strong ability to critically assess clinical literature, support
Master’s degree in the clinical sciences required. PharmD, MD, NP/PA preferred
Clinical experience in emergency medicine, critical care or inpatient medicine preferred
3+ years of clinical experience (working in clinical environment or clinical research) required; prior experience with medical device quality systems preferred.
Working knowledge of global regulations and standards related to the conduct of medical device/drug clinical studies preferred
Experience creating and maintaining Clinical Evaluation Reports and Literature Reviews preferred
Knowledge of research methodology, information management, and experience with research databases (ie. Embase and Medline) and medical writing strongly preferred
Excellent organizational, critical thinking and problem-solving skills
Excellent technical writing and verbal communication skills including ability to interact with executive level management and regulatory inspectors
Understand LEAN concepts, methodologies and deployment
May require 15% travel annually with possibly some international
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global 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. Furthermore, Philips University is available to all employees for learning and development opportunities.
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. Learn more by watching this video.
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 race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
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.
Equal Employment and Opportunity Employer/Disabled/Veteran