Director of Clinical Operations

Philips • San Diego, CA

1d • $171,000 - $306,000 • Onsite

About The Position

The Director of Clinical Operations, Image Guided Therapy Devices (IGTD), oversees day-to-day clinical program operations and ensures progress against goals. The role leads complex negotiations with regulatory bodies, sites, and vendors, and streamlines operations through innovative methodologies. It partners with executive leadership and cross-functional teams across IT, Clinical/Medical, Regulatory, Legal, Quality, Procurement, and Finance to shape research strategy, analyze industry trends, advise stakeholders, manage vendors and deliverables as Product Owner, and report to senior leadership and regulatory authorities.

The director leads operational planning and execution of clinical trials and evidence-generation programs across Coronary, Peripheral, and Cardiac Solutions. Programs include early feasibility, pivotal, pre-market, post-market, registry, real-world evidence, investigator-initiated, and company-sponsored studies. The role translates evidence strategies and protocols into plans for timelines, enrollment, site activation, monitoring, vendors, budgets, resourcing, and risk mitigation.

The role oversees study startup and execution, including site feasibility and selection, contracts and budgets, ethics committee and IRB submissions, site initiation, enrollment, monitoring, data collection, protocol compliance, deviations, adverse events, documentation, and closeout. It ensures inspection readiness and compliance with ICH GCP, ISO standards, FDA and global regulatory requirements, local requirements, and Philips policies. It also partners with Regulatory, Quality, and Clinical Affairs on submissions, clinical evaluations, annual reports, post-market surveillance, and evidence delivery.

The director manages clinical operations governance and external partner performance, builds and develops a high-performing team, and represents Clinical Operations in governance forums, product development discussions, senior management reviews, and external discussions. This is an office-based role with an expectation to work in person at least three days per week. Domestic and international travel is approximately 20–30% of the time.

Requirements

• 10+ years of directly related clinical research or clinical operations experience.
• 5+ years leading or managing clinical operations teams.
• 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, including study startup, site activation, enrollment, monitoring, vendor management, data collection, closeout, inspection readiness, budgets, contracts, timelines, site performance, vendor deliverables, and operational risk.
• 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.
• Ability to translate strategy and study design into practical trial plans; build collaborative relationships; influence through direct and indirect reporting lines; and communicate effectively with clinical, regulatory, technical, executive, vendor, and external audiences.
• Ability to supervise exempt and non-exempt employees and support hiring and performance management decisions.
• Ability to travel domestically and internationally approximately 20–30% of the time.
• Must reside in or within commuting distance of the posted locations.
• US work authorization is required; candidates needing sponsorship for a work-authorized visa now or in the future will not be considered.

Nice To Haves

• Experience within the medical device industry.
• Advanced scientific, clinical, regulatory, public health, or business degree.
• Experience with cardiovascular, peripheral vascular, coronary, electrophysiology, structural heart, image guided therapy, or catheter-based technologies.
• Experience with global clinical trial execution and digital clinical trial systems.

Responsibilities

• 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 for timelines, enrollment, site activation, monitoring, vendors, budgets, resources, 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, patient enrollment, monitoring, data collection, protocol compliance, deviation management, adverse event workflows, documentation, and closeout.
• Ensure clinical studies are inspection ready and comply with ICH GCP, ISO standards, FDA and global regulatory requirements, local country requirements, and Philips quality and compliance policies.
• Partner with Regulatory, Quality, and Clinical Affairs on regulatory submissions, clinical evaluations, annual reports, post-market surveillance, and timely delivery of high-quality evidence.
• Manage clinical operations governance, vendor oversight, and performance across CROs, core and imaging laboratories, data management partners, safety vendors, electronic data capture providers, and other study partners.
• Establish study team meetings, enrollment reviews, budget reviews, milestone tracking, risk escalation, and senior leadership updates.
• Build, lead, and develop a high-performing Clinical Operations team with clear goals, accountability, collaboration, execution discipline, and continuous improvement.
• Represent Clinical Operations in governance forums, core team meetings, product development discussions, senior management reviews, and external discussions with investigators, vendors, and regulatory authorities as needed.
• Supervise exempt and non-exempt employees; oversee vendors and external partners; and support hiring and performance management decisions.
• Travel domestically and internationally approximately 20–30% of the time.

Benefits

• Generous PTO
• 401(k) with up to 7% match
• HSA with company contribution
• Stock purchase plan
• Education reimbursement
• Comprehensive Philips Total Rewards benefits program
• Annual incentive bonus, sales commission, or long-term incentives may be offered

What This Job Offers

• Job Type: Full-time
• Career Level: Director