Senior Clinical Development Scientist

Job Title

Senior Clinical Development Scientist

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.

• 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, IRB's/EC's, Regulatory Agencies, societies, and associations; and additionally, 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 the process of clinical evidence generated for marketing authorization, in‑line extensions, including during sponsor regulatory inspections.

• 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 proven experience in setting up real‑world registries and post‑market health outcome development studies.
• 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 are able to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications.
• You are able to collaborate effectively, influence decision making with internal/external stakeholders and cross‑functional teams.
• You have an analytical mindset, 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.

We believe that we are better together than a part. For our Office‑based teams
, this means working in‑person at least three 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
.

• The pay range for this position in Bothell, WA and Cambridge, MA is $148,000 to $237,000.

• 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%.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.