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.
