Director of Clinical Operations

Job Title

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.

Youre 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 bachelors 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 2030% 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 companys facilities. Field roles are most effectively done outside of the companys 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 wont 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 $171000 to $273000.

The pay range for this position in Plymouth MN is $180000 to $287000.

The pay range for this position in Bothell WA San Diego CA Cambridge MA Bedford MA is$192000 to $306000.

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.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

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