Clinical Development Scientist

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
• 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
  
  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
• 3+ 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.)
• Project/timeline management skills and organizational skills
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this
  
  How we work together
We believe that we are better together than apart. 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 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 healthcare that we all deserve. Do the work of your life to help improve the lives of others.
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. Philips Transparency Details The pay range for this position in (Cambridge, MA) is $105,000 to $180,000 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 . 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., 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 Cambridge, MA. 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.