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 devicesYour 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
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
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 position.
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Philips Transparency DetailsThe pay range for this position in (Cambridge, MA) is $105,000 to $180,000The 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.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.Additional InformationUS 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 .It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran