Director of Clinical Operations

Philips•San Diego, CA

1d•$171,000 - $306,000•Hybrid

About The Position

The Director of Clinical Operations, IGTD, oversees day-to-day clinical program operations, ensuring progress against goals while leading complex negotiations with regulatory bodies, sites, and vendors and streamlining operations through innovative methodologies. This role partners with executive leadership and cross-functional teams across IT, Clinical/Medical, Regulatory, Legal, Quality, Procurement, and Finance to shape large-scale research strategy, analyze industry trends, advise stakeholders, manage vendors and deliverables as Product Owner, and provide clear reporting to senior leadership and regulatory authorities.

Requirements

10+ years of directly related clinical research or clinical operations experience, preferably within the medical device industry
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 includes 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
Strong clinical operations leader who can translate strategy and study design into practical trial plans, build collaborative relationships, influence through direct and indirect reporting lines, communicate effectively with clinical, regulatory, technical, executive, vendor, and external audiences, and create a culture of accountability, process improvement, and excellence
Able to supervise exempt and non-exempt employees, oversee vendors and external partners, support hiring and performance management decisions
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Must reside in or within commuting distance to posted locations.

Nice To Haves

An advanced scientific, clinical, regulatory, public health, or business degree is 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 is highly desirable

Responsibilities

Lead the operational planning and execution of clinical trials and evidence generation programs across Coronary, Peripheral, and Cardiac Solutions, including early feasibility, pivotal, pre-market, post-market, registry, real-world evidence, and investigator-initiated or company-sponsored studies.
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, contract and budget coordination, ethics committee and IRB submissions, site initiation, patient enrollment, monitoring, data collection, protocol compliance, deviation management, adverse event workflows, documentation, and closeout.
Ensure all clinical studies are inspection ready and executed in accordance 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 to support regulatory submissions, clinical evaluations, annual reports, post-market surveillance needs, and timely delivery of high-quality evidence outputs.
Manage clinical operations governance, vendor oversight, and performance management across CROs, core and imaging laboratories, data management partners, safety vendors, electronic data capture providers, and other external study partners.
Establish operating rhythms for 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, execution discipline, collaboration, 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.