Senior Clinical Development Scientist

About the role

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.

Responsibilities

• 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.

Requirements

• 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.
• Proven experience in setting up real world registries and post market health outcome development studies.
• Expertise in innovative clinical trial/study design, registries, quality improvement initiatives, creation of data networks and working knowledge of biostatistics.
• Demonstrated working knowledge of GCP, FDA and EU-MDR regulations, in-depth understanding of product development and associated design controls for medical devices.
• Strong writing skills to produce quality clinical documents, including CEPs, CERs, PMCFPS documentation 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.
• Ability to collaborate effectively, influence decision making with Internal/External stakeholders and cross-functional teams.
• An analytical mind-set, with the ability to present statistical methods and results to a variety of audiences, especially non-statisticians.
• A minimum of a Master’s Degree in Life Sciences, Medical Field or comparable disciplines. MD or Ph.D. desired.

Qualifications

• Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements for this Clinical position.

Skills

• Acquire 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.
• Proven experience in setting up real world registries and post market health outcome development studies.
• Expertise in innovative clinical trial/study design, registries, quality improvement initiatives, creation of data networks and working knowledge of biostatistics.
• Demonstrated working knowledge of GCP, FDA and EU-MDR regulations, in-depth understanding of product development and associated design controls for medical devices.
• Strong writing skills to produce quality clinical documents, including CEPs, CERs, PMCFPS documentation 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.
• Ability to collaborate effectively, influence decision making with Internal/External stakeholders and cross-functional teams.
• An analytical mind-set, with the ability to present statistical methods and results to a variety of audiences, especially non-statisticians.
• A minimum of a Master’s Degree in Life Sciences, Medical Field or comparable disciplines. MD or Ph.D. desired.

Benefits

Details about our benefits can be found here.

Pay

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

Schedule

This is an Office-based role. May travel up to 15%.