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Philips · 2 days ago

Senior Manager-Clinical Development- Patient Monitoring

Cambridge, MA

Full-time

Onsite

Senior Level, Lead/Staff

$145K/yr - $232K/yr

10+ years exp

Philips is a health technology company dedicated to improving healthcare access for everyone. The Senior Manager-Clinical Development will oversee clinical programs related to patient monitoring, ensuring compliance, efficiency, and cross-departmental collaboration.

B2BConsumer ElectronicsElectronicsLightingWellness

No H1B

Responsibilities

Responsible for planning, direction, and coordination of clinical programs and activities, including overseeing Clinical Evidence planning and generation, Clinical PIL tools, process implementation, ensuring compliance with applicable laws, regulations, and standards

Ensures accountability for process execution, system functionality, backlog management, and improvement initiatives

Assists in the updates and enhancement of quality system processes for Clinical & Medical Affairs, aligning with business strategies, roadmaps, and Informatics demands

Serves as a primary point of contact between Clinical & Medical Affairs and other departments, driving cross-function cooperation and ensuring stakeholder alignment

Coordinates change requests and submissions, ensuring all critical parties are aligned and changes are effectively implemented

Works with a diverse global team, emphasizing project management, business analysis, service management, solution ownership, and validation to achieve targeted outcomes

Promotes application standardization through shared processes, data harmonization, and architectural compliance, while fostering strong relationships

Leverages expertise in Clinical & Medical Affairs to propose innovative ideas that support the function meeting their objectives

Ensures compliance with training requirements and driving continuous improvement for the clinical programs

Supports the development of the Clinical & Medical Affairs team by sharing resources, knowledge, and experience, and leading initiatives that enhance the organization

Qualification

Clinical ResearchMedical Device DevelopmentProject ManagementClinical ValidationHealth Care ResearchTeam LeadershipSix SigmaAgilePMP CertificationCommunication Skills

Required

You have a minimum of 10+ years' combined experience in Medical Device Clinical Research and Medical Device development within FDA regulated OEM product environments

You have proven experience in clinical validation, measurement, sustaining, as well as design, execution and oversight of clinical research, planning and associated technologies/tools

You have a minimum of 3+ years' experience in Project/Program management and/or Team leadership, with proven experience in budgeting, training, staff development, resource allocation, continuous improvement, etc

You have a detailed understanding of Clinical & Medical Affairs, leveraging expertise to propose innovative ideas, providing meaningful input and contribute to senior leadership discussions

You have a deep understanding of Health Care Research methodology, regulations, laws, and guidance in major markets such as EU, USA, UK, AUS, Japan and China

You have proven experience in building/Cultivating strong working relationships and partnerships with business stakeholders/functions and influencing internal/external service providers towards achieving strategic objectives

You have a minimum of a Bachelors' Degree (Required) in Biology, Health Science MPH, Nursing or equivalent

You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position