Director of Clinical Operations

Philips

. Lead operational planning and execution of clinical trials and evidence generation programs across Coronary, Peripheral, and Cardiac Solutions .

Posted 10/14/2026full-timeUnited StatesLead💰 $171,000 - $306,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in clinical trial execution, regulatory compliance, and operational leadership within the medical device industry. Proven ability to manage complex clinical studies, oversee clinical operations teams, and ensure adherence to ICH GCP, FDA regulations, and ISO standards.

Highest-signal resume keywords

Clinical Trial ExecutionRegulatory ComplianceTeam LeadershipBudget ManagementVendor Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchClinical Operations ManagementICH GCPISO 14155FDA Medical Device RegulationsProtocol Deviation ManagementAdverse Event ReportingTrial Master File ManagementData CollectionRisk Mitigation

Soft Skills

LeadershipCommunicationCollaborationProblem-SolvingPerformance Management

Tools & Technologies

EDC ProvidersDigital Clinical Trial SystemsData Management Partners

Industry Keywords

Medical Device IndustryCardiovascularPeripheral VascularCoronaryElectrophysiologyStructural HeartImage Guided TherapyCatheter-Based TechnologiesGlobal Clinical Trial ExecutionClinical Operations Governance

About the role

Key responsibilities & impact

Lead operational planning and execution of clinical trials and evidence generation programs across Coronary, Peripheral, and Cardiac Solutions
Translate clinical evidence strategies and protocols into executable plans covering timelines, enrollment, site activation, monitoring, vendors, budgets, resourcing, and risk mitigation
Oversee end-to-end study startup and execution, including site feasibility, investigator selection, contracts and budgets, ethics committee and IRB submissions, site initiation, enrollment, monitoring, data collection, protocol compliance, deviations, adverse events, documentation, and closeout
Ensure studies are inspection ready and comply with ICH GCP, ISO standards, FDA and global regulatory requirements, local country requirements, and Philips policies
Partner with Regulatory, Quality, and Clinical Affairs on regulatory submissions, clinical evaluations, annual reports, post-market surveillance, and evidence outputs
Manage clinical operations governance, vendor oversight, and performance across CROs, laboratories, data management partners, safety vendors, EDC providers, and other study partners
Establish operating rhythms for study meetings, enrollment reviews, budget reviews, milestone tracking, risk escalation, and senior leadership updates
Build, lead, and develop a high-performing Clinical Operations team
Represent Clinical Operations in governance forums, core team meetings, product development discussions, management reviews, and external discussions

Requirements

What you’ll need

10+ years of directly related clinical research or clinical operations experience
5+ years leading or managing clinical operations teams
Preferably experience within the medical device industry
Demonstrated track record of delivering complex clinical studies on time, within budget, and in compliance with applicable requirements
Deep knowledge of clinical trial execution across the product lifecycle
Expertise in ICH GCP, ISO 14155, FDA medical device regulations, informed consent, adverse event reporting, protocol deviation management, clinical trial documentation, trial master file expectations, and global regulatory and operational requirements
Bachelor’s degree in a scientific, clinical, health sciences, engineering, or related discipline
Advanced scientific, clinical, regulatory, public health, or business degree preferred
Experience with cardiovascular, peripheral vascular, coronary, electrophysiology, structural heart, image guided therapy, catheter-based technologies, global clinical trial execution, and digital clinical trial systems highly desirable
Ability to supervise exempt and non-exempt employees, oversee vendors and external partners, and support hiring and performance management decisions
Ability to travel domestically and internationally approximately 20–30% of the time
Must successfully perform minimum physical, cognitive, and environmental job requirements with or without accommodation
US work authorization required; candidates requiring sponsorship now or in the future will not be considered
Must reside in or within commuting distance to posted locations

Benefits

Comp & perks

Generous PTO
401k with up to 7% match
HSA with company contribution
Stock purchase plan
Education reimbursement
Annual incentive bonus may be offered
Long-term incentives may be offered
Company relocation benefits will not be provided