Senior Clinical Development Scientist

Philips

Bothell, WA

Apply

JOB DETAILS

SALARY

$148,000–$237,000 Per Year

SKILLS

Algorithms, Analysis Skills, Artificial Intelligence (AI), Biology, Biostatistics, Brochures, Clinical Assessment, Clinical Medicine, Clinical Research, Clinical Study Publications, Clinical Trial, Clinical Validation, Compensation and Benefits, Computer Networks, Cross-Functional, Documentation, Drug Development, Environmental Work, FDA (Food and Drug Administration), GCP (Good Clinical Practices), Health Economics, Healthcare Quality, Healthcare Reimbursement, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Marketing, Medical Equipment, Presentation/Verbal Skills, Product Development, Product Lifecycle Management, Product Programs, Quality Assurance, Quality Management, Regulations, Regulatory Reports, Regulatory Requirements, Regulatory Submissions, Reimbursement, Scientific Publications, Stock Purchase Plans, Team Player, Ultrasound, Writing Skills

LOCATION

Bothell, WA

POSTED

5 days ago

The Senior Clinical Development Scientist will be responsible for developing, generating, and disseminating clinical/economic evidence for Philips Ultrasound products, 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. + Participate 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 and 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 a minimum of 7+ years' clinical experience within FDA regulated medical device environments, with a focus on clinical research/development/real world evidence (RWE); strong scientific background and experience with Artificial Intelligence algorithm clinical performance validation. + You have expertise in innovative clinical trial/study design, registries, quality improvement initiatives, creation of data networks and working knowledge of biostatistics. + You have demonstrated working knowledge of GCP, FDA and EU-MDR regulations, in-depth understanding of product development and associated design controls for medical devices. + You have strong writing skills to produce quality clinical documents, including CEPs, CERs, PMCFPS documentation and final reports + You're able to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications. + You're able to collaborate effectively, influence decision making with Internal/External stakeholders and cross-functional teams. + You have an analytical mind-set, with the ability to present statistical methods and results to a variety of audiences, especially non-statisticians. + You have a minimum of a Master's Degree in Life Sciences, Medical Field or comparable disciplines. MD or Ph.D. desired. + You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Clinical position. **How we work together:** We believe that we are better together than a part. For our **_Office-based teams_** , this means working in-person **at least 3 days per week** . Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an **_Office-based role._** **About Philips:** We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of 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. + Learn more about our culture. **Philips Transparency Details:** + The pay range for this position in **_Bothell, WA_** _and_ **_Cambridge, MA_** is $148,000 to $237,000 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. The actual base pay offered may vary within the posted ranges 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. **Additional Information:** + US 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 **_Bothell, WA_** _or_ **_Cambridge, MA_** + May travel up to **15%** **\#LI-PH1** 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

About the Company

Philips

At Philips, we don’t need employees. We need people.

Our goal is to improve the lives of 3 billion people a year by 2025 through innovation that is designed for people, by people. People like you. And we know that in order to be truly innovative, it requires you to make your career personally meaningful. To bring what matters to you in life to everything you do in your career. If you're passionate about improving lives, and have more to offer than just lines on your resume, we want to find a home for you at Philips.

As a diversified health and well-being company, we focus on professional and consumer markets across three interconnected sectors: Healthcare, Consumer Lifestyle, and Lighting. Today, we're a global innovation leader - the first to bring the commonly used CD and DVD products to market, the ones saving lives daily with our imaging systems and patient monitors, and the ones responsible for the lighting of the annual Times Square ball. We aim to improve peoples’ lives every day through meaningful innovations and are the best place to work for those who share our passion for improving lives.

Philips’ people first culture and commitment to providing unlimited possibilities to develop one's career in the directions to which they aspire demonstrates a dedication to inspiring good people, not just hiring employees. At Philips, employees enjoy contributing to cutting edge solutions that truly improve lives, allowing them to 'do good' while doing great and create a legacy in life through their work.

If you are interested in putting your personal skills & passions to work towards improving lives, apply now or learn more at philips.com/na/careers. You can also opt-in to receive updates on future career opportunities and company updates through Philips’ Talent Community, and follow @PhilipsJobsNA on Twitter.

COMPANY SIZE

10,000 employees or more

INDUSTRY

Other/Not Classified

FOUNDED

1933

WEBSITE

http://www.philips.com/na/careers

Resume Resources

Free Resume Templates Free Resume Builder