Associate Director-Clinical Operations

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 Associate Director- Clinical Operations, is responsible for day-to-day Clinical Operations/team Management and providing expertise in clinical research process legislation, ICH-GCP guidelines, improving efficiency in clinical execution.
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' Clinical Operations experience within Medical Device Clinical Research and FDA regulated OEM Medical Device product environments. Experience in Patient Monitoring (desired).
• You have a minimum of 3+ years' experience in functional management of Clinical teams, including budgeting, training, staff development, performance management, resource management (overseeing the allocation of personnel, materials, and other resources to meet project oranizational goals), continuous improvement, etc.
• You have proven expertise in leading Clinical Operations, execution, research process legislation, ICH-GCP guidelines, planning and associated technologies/tools.
• 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.
• 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).
• Master's/PhD desired.
• Six Sigma, Safe, Agile, PMP certifications desired.

Responsibilities

• Planning, direction, and coordination of clinical programs and activities
• Overseeing Clinical Evidence planning and generation
• Overseeing 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
• Serves as a primary point of contact between Clinical & Medical Affairs and other departments
• Coordinates change requests and submissions
• Works with a diverse global team
• Promotes application standardization through d processes, data harmonization, and architecturalpliance
• Leverages expertise in Clinical & Medical Affairs to propose innovative ideas
• Ensurespliance with training requirements and driving continuous improvement for the clinical programs
• Supports the development of the Clinical & Medical Affairs team

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: Director
• Number of Employees: 5,001-10,000 employees