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Senior Clinical Development Scientist

$148k - $237k

Mass Digital Health

Senior Clinical Development Scientist Job Description The Senior Clinical Development Scientist will be responsible for developing, generating, and disseminating clinical and 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 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 the course of design, execution, and interpretation of trial data. Collaborate with investigators, IRBs, Regulatory Agencies, societies, and associations; and support claims, reimbursement, health economic outcomes and/or market access. Participate in clinical evaluation documentation, including guidance on post‑market clinical follow‑up initiatives and clinical investigation documents in accordance with applicable regulatory standards. Ensure appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, Clinical Evaluation Reports, abstracts, and peer‑reviewed manuscripts, as assigned. Lead and support scientific discussions with regulatory agencies or notified bodies, including proposed clinical investigations; review the process of clinical evidence generated for marketing authorization, in‑line extensions, including during sponsor regulatory inspections. Qualifications Minimum 7+ years of clinical experience within FDA‑regulated medical device environments, with a focus on clinical research, development, real‑world evidence, and a strong scientific background with experience in validating AI algorithms. Expertise in innovative clinical trial and study design, registries, quality improvement initiatives, data network creation, and a working knowledge of biostatistics. Working knowledge of GCP, FDA and EU‑MDR regulations, and an in‑depth understanding of product development and associated design controls for medical devices. Strong writing skills to produce quality clinical documents, including CEPs, CERs, PMCF documents, and final reports. Ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports, and scientific publications. Strong collaboration skills, influencing decision making with internal and external stakeholders and cross‑functional teams. Analytical mindset, with the ability to present statistical methods and results to a variety of audiences, especially non‑statisticians. Minimum Master’s Degree in Life Sciences, Medical Field or comparable disciplines; MD or Ph.D. desired. Work Arrangement Office‑based role. Work in‑person at least 3 days per week at the company’s facilities. Field roles are performed outside the company’s main facilities, typically at customers’ or suppliers’ locations. Benefits The pay range for this position in Bothell, WA and Cambridge, MA is $148,000 to $237,000. Complete benefits package includes paid time off, 401(k) with up to 7% match, HSA with company contribution, stock purchase plan, education reimbursement, and more. US work authorization is required and candidates who require visa sponsorship will not be considered. Additional Information Company relocation benefits will not be provided. Candidates must reside in or near Bothell, WA or Cambridge, MA. Travel up to 15% may be required. Philips is an Equal Employment Opportunity Employer, including Disability and Veterans, and maintains a drug‑free workplace. #J-18808-Ljbffr Mass Digital Health

Vacancy posted 3 days ago
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