Clinical Development Scientist

Role Purpose

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.