Director of Clinical Operations

Philips; Massachusetts; Vor Ort; USD 192.000 - 306.000; Vollzeit

Zusammenfassung

Philips in Massachusetts seeks a Director of Clinical Operations IGTD to lead day-to-day clinical program operations across coronary, peripheral, and cardiac solutions. You will shape study startups, site activation, enrollment, monitoring, budget coordination, and vendor management while ensuring compliance with ICH GCP, ISO standards, and FDA requirements.

You will partner with Regulatory, Quality, Clinical Affairs, and executive leadership, drive risk mitigation, and deliver high-quality

Qualifikationen

• 10+ years in clinical research or clinical operations.
• 5+ years leading clinical operations teams.
• Deep knowledge of ICH GCP, ISO standards, FDA regulations.

Aufgaben

• Lead day-to-day clinical program operations across coronary, peripheral, and cardiac solutions.
• Manage study startup, site activation, enrollment, monitoring, and vendor oversight.
• Coordinate budgets, contracts, and risk management with cross-functional teams.
• Ensure inspection readiness and regulatory compliance across studies.
• Partner with Regulatory, Quality, Clinical Affairs and senior leadership.

Kenntnisse

Clinical operations

Vendor management

ICH GCP

Regulatory submissions

Budget management

Stakeholder leadership

Ausbildung

Bachelor's degree in a scientific field

Advanced degree preferred

Tools

EDC systems

Regulatory submission tools

Jobbeschreibung

Job Title Director of Clinical Operations Job Description Director of Clinical Operations, Image Guided Therapy Devices

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.

Your role:

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.

You're the right fit if:

You have acquired 10+ years of directly related clinical research or clinical operations experience, preferably within the medical device industry, including 5+ years leading or managing clinical operations teams. You have a demonstrated track record of delivering complex clinical studies on time, within budget, and in compliance with applicable requirements. You have 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. Your 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. You have a bachelor’s degree in a scientific, clinical, health sciences, engineering, or related discipline; 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. You are a 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. You are able to supervise exempt and non-exempt employees, oversee vendors and external partners, support hiring and performance management decisions, and travel domestically and internationally approximately 20-30% of the time. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office-based role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture.

Philips Transparency Details

The pay range for this position in Colorado Springs is $171,000 to $273,000. The pay range for this position in Plymouth, MN is $180,000 to $287,000. The pay range for this position in Bothell, WA, San Diego, CA, Cambridge, MA, Bedford, MA is $192,000 to $306,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

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. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to posted locations.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people’s lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That’s why we’re taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other’s views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by §503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.