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Philips · 1 week ago

Associate Director-Clinical Operations

Cambridge, MA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$145K/yr - $232K/yr

10+ years exp

Philips is a health technology company dedicated to improving healthcare access for everyone. The Associate Director-Clinical Operations will oversee clinical programs and activities, ensuring compliance with regulations while enhancing the efficiency of clinical execution.

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 Operations experienceICH-GCP guidelinesClinical & Medical AffairsHealth Care Research methodologySix Sigma certificationProject managementBudgetingStaff developmentPerformance managementResource managementContinuous improvementAgile certificationPMP certificationTeam management

Required

Minimum of 10+ years' Clinical Operations experience within Medical Device Clinical Research and FDA regulated OEM Medical Device product environments

Minimum of 3+ years' experience in functional management of Clinical teams, including budgeting, training, staff development, performance management, resource management, continuous improvement

Proven expertise in leading Clinical Operations, execution, research process legislation, ICH-GCP guidelines, planning and associated technologies/tools

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

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

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

Minimum of a Bachelors' Degree in Biology, Health Science MPH, Nursing or equivalent

Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation