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Clinical Development Scientist
4 months ago
Clinical Development Scientist (Cambridge, MA)
The Clinical Development Lead will primarily focus on study design strategy for the development of clinical study protocols and support the clinical operations team with study execution. This person will apply epidemiology principles and methods to the clinical setting to support evidence generation across the Hospital Patient Monitoring businesses, particularly for cardiovascular and hemodynamic monitoring devices
Your role:
- Provide strategic guidance on the design and development of clinical study protocols, including retrospective and prospective data collection methodologies
- Support the design and execution of key elements of the Clinical Development Plan and associated data collection activities, within the Hospital Patient Monitoring business group
- Defining clinical questions, study end-points, identifying relevant evidence, critically apprising evidence, and applying evidence to substantiate clinical and medical device claims
- Identify innovative methods to improve efficiency of collecting evidence and assessing risk of bias
- Collaborate on, or lead where appropriate, calls with regulatory agencies (FDA, EMA) to support clinical trial regulatory submissions
- Liaise with other functions to enable quality clinical study execution as the study design subject matter expert
- Collaborate with the clinical study team in site identification and selection, and provide assistance with study start-up activities
- Participate in Investigator meeting planning and execution and/or on-site initiation meetings
- Serve as internal Principal Investigator on Philips sponsored studies where needed
- Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
- Contribute to statistical methodologies to validate study objectives
- Contribute to authoring of manuscripts, conference presentations, and other dissemination activities
You're the right fit if:
- Scientific degree (BS, M.S., MPH, Ph.D., or similar degree) in the health sciences, life sciences, clinical sciences or biomedical engineering, with experience in cardiology and hemodynamic monitoring
- 2+ years of experience in the design and execution of clinical or medical device studies, including retrospective and prospective designs
- Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
- Experience and skill performing systematic medical/ scientific literature searches (PubMed, Google Scholar, etc.)
- Ability to clearly communicate to internal and external stakeholders orally and in writing, including management, academicians, clinicians, and scientists
- Excellent English written and oral communications skills-- strong attention to detail related to consistency, grammar, syntax, and accuracy
- Demonstrated ability to work in a (virtual) team environment, including leading discussions and presenting to internal business and regulatory stakeholders
- Project/timeline management skills and organizational skills
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 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.
- Read more about our employee benefits.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion 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.
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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/Disabled/Veteran and maintains a drug-free workplace.
