Senior Manager-Clinical Development- Patient Monitoring

Koninklijke Philips N.V • Cambridge, MA

5d • Onsite

About The Position

As an important member of our talented Hospital Patient Monitoring (HPM) Clinical Affairs team, the Senior Manager-Clinical Development is responsible for managing the day-to-day operations of Clinical Measurements & Specialty Monitoring clinical programs, improving efficiency and simplifying the planning/execution of clinical plans.
Your role:
Responsible for planning, direction, and coordination of clinical programs and activities, including overseeing Clinical Evidence planning and generation, Clinical PIL tools, process implementation, ensuringpliance 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 oues.
Promotes application standardization through d processes, data harmonization, and architecturalpliance, while fostering strong relationships.
Leverages expertise in Clinical & Medical Affairs to propose innovative ideas that support the function meeting their objectives.
Ensurespliance 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 theanization.

Requirements

• You have a minimum of 10+ years'bined 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. Experience in Patient Monitoring (desired).
• 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. Master's/PhD desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without amodation for this position.
• US work authorization is a precondition of employment.
• For this position, you must reside in or withinmuting distance to Cambridge, MA.

Nice To Haves

• Experience in Patient Monitoring (desired).
• Six Sigma, Safe, Agile, PMP certifications desired.

Responsibilities

• Responsible for planning, direction, and coordination of clinical programs and activities, including overseeing Clinical Evidence planning and generation, Clinical PIL tools, process implementation, ensuringpliance 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 oues.
• Promotes application standardization through d processes, data harmonization, and architecturalpliance, while fostering strong relationships.
• Leverages expertise in Clinical & Medical Affairs to propose innovative ideas that support the function meeting their objectives.
• Ensurespliance 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 theanization.

Benefits

• Employees are eligible to participate in ourprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (withpany contribution), stock purchase plan, education reimbursement and .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees