Description

Job Title
Senior Clinical Development Scientist

Job Description

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 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'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%

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This 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 including Disability/Vets and maintains a drug-free workplace.