Clinical Development Scientist

Job Summary – Clinical Development Scientist (Cambridge, MA) Support the design, execution, and regulatory submission of clinical studies for hospital monitoring devices (especially cardiovascular and hemodynamic monitoring) to ensure safety, effectiveness, and compliance. Key Responsibilities Provide strategic guidance on clinical study protocol design (retrospective and prospective). Develop and implement clinical development plans and data collection activities. Define clinical questions, endpoints, and identify/appraise evidence to substantiate device claims. Identify innovative and efficient methods for evidence collection and risk of bias assessment. Collaborate with regulatory agencies (FDA/EMA) to support clinical trial submissions. Serve as study design subject matter expert; liaise with cross‑functional teams for study execution. Assist with site identification, selection, and study start‑up activities. Participate in investigator meetings and on‑site study initiations. Act as internal Principal Investigator on Philips-sponsored studies as needed. Support and advise CRAs/CROs on study protocols and procedures. Engage with investigators, site staff, CROs, and monitors to support study enrollment. Contribute to statistical methodologies and validation of study objectives. Assist with authoring manuscripts, conference presentations, and other dissemination activities. Review and synthesize scientific literature and competitive intelligence. Manage project timelines and ensure milestones are met. Maintain in-depth knowledge of competitor devices and relevant clinical/market developments. Ensure compliance with Good Documentation Practices, SOPs, GCP, and regulatory guidelines. Up to 20% travel required (regional/international). Required Qualifications Advanced degree (M.S., MPH, Ph.D., or similar) in health/life/clinical sciences or biomedical engineering. 2+ years’ experience designing/executing clinical or medical device studies. Knowledge of clinical research methodology, statistics, data analysis, and interpretation. Experience with systematic scientific literature searches (e.g., PubMed, Google Scholar). Excellent written and verbal communication skills (English). Strong project/timeline management, organization, and prioritization skills. Ability to work independently and as part of a (virtual) team. Proficiency with Microsoft Office. Preferred Qualifications Experience with EN ISO 14155 (Clinical Investigations) and ISO 14971 (Risk Management). Prior experience with patient monitoring devices. Familiarity with medical device regulations and standards. #J-18808-Ljbffr