Senior Clinical Development Scientist
12 hours ago
Job TitleSenior Clinical Development ScientistJob DescriptionSenior Clinical Development Scientist (Bothell, WA preferred or Cambridge, MA)The Senior Clinical Development Scientist for the Ultrasound group will be responsible for developing, generating, and disseminating clinical and economic evidence ensuring innovation, and transformation with best-in-class clinical evidence.Your role:Contribute strategic guidance for clinical and economic evidence related to the end to end (E2E) development process from ideation through post-market for products in the Ultrasound business.Collaborate with key internal and external stakeholders to provide in-depth expertise to develop and lead clinical initiatives through non-clinical and clinical strategies for new product development initiatives and product life cycle management.Drive execution ensuring quality and timeliness of clinical programs and/or trials to support critical regulatory requirements, be agile and responsive during course of design, execution, and interpretation of trial data.Collaborate with investigators, IRB’s/EC’s, Regulatory Agencies, societies, and associations; and additionally, to support claims, reimbursement, health economic outcomes and/or market access.Participated in clinical evaluation documentation including guidance on Post Market Clinical Follow Up (PMCF) initiatives and clinical investigation documents in accordance with applicable regulatory standards.Ensure appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, as assigned.Lead or support scientific discussions with regulatory agencies or notified bodies, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, in line extensions, including during sponsor regulatory inspections.You are the right fit if: You have acquired 7+ years of experience in clinical research/development/real world evidence (RWE); medical devices experience strongly preferred. Experience with class 3 devices preferred but not required.Your skills include a demonstrated working knowledge of GCP, FDA regulations and EU-MDR regulations, and in-depth understanding of product development and associated design controls for medical devices. You have strong writing skills to product quality clinical documents, including final reports. Strong knowledge and experience with study design is also desired.You have a medical or scientific education (MD or PhD strongly preferred or MS in a relevant field with equivalent industry experience).You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Clinical position.You are self-directed with a strong work ethic, agile, and have an ability to work in a purposeful environment. You can collaborate effectively and influence decision making with various teams cross-functionally, as well as externally. You can think analytically, present statistical methods and results to a variety of audiences, especially non-statisticians. You can travel up to 15% (domestic and international) according to business needs.About PhilipsWe are a health technology company. We built our entire company around the belief that every human matters, and we will not stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.Learn more about our business.Discover our rich and exciting history.Learn more about our purpose.Read more about our employee benefits.If you are interested in this role and have many, but not all, of the experience needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.Philips Transparency Details The pay range for this position is $130,144 to $223,104 annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to the posted location.#LI-PH1This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.Job SummaryJob number: 529760Date posted : 2024-10-07Profession: Health, Clinical and Medical SafetyEmployment type: Full time
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