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# VP, Clinical Operations with a Medical Device Company – Irvine, CA


Role Overview for VP, Clinical Operations with a Medical Device Company – Irvine, CA
JRG Partners is proud to be the exclusive search partner for a pioneering medical device company at the forefront of technological innovation. Located in the vibrant med-tech hub of Irvine, California, our client is dedicated to developing life-changing devices that address critical unmet medical needs. They have built a reputation for scientific rigor, engineering excellence, and a patient-centric culture. We are seeking a visionary and strategic Vice President of Clinical Operations to join their executive leadership team and steer the clinical development programs that will shape the future of healthcare.
As the VP of Clinical Operations, you will be the principal architect of the company’s clinical strategy and the driving force behind its execution. This is a highly visible, mission-critical role responsible for providing leadership, direction, and oversight for all aspects of clinical trial planning, implementation, and completion.
You will lead a talented team of clinical professionals, ensuring that all clinical studies are conducted with the highest standards of quality, ethical conduct, and regulatory compliance. Your leadership will be instrumental in generating the robust clinical evidence needed to achieve regulatory approvals, support market adoption, and ultimately improve patient outcomes globally. This position requires a dynamic leader who can seamlessly blend strategic thinking with hands-on operational expertise, fostering a culture of excellence, collaboration, and urgency within the clinical department and across the entire organization.
The ideal candidate is a seasoned leader with an extensive track record in the medical device industry, possessing a deep understanding of the complex regulatory landscapes in the US and abroad. You will be responsible for building and mentoring a world-class team, managing significant budgets, and collaborating effectively with cross-functional leaders in R&D, Regulatory Affairs, Quality, and Commercial teams. If you are a passionate and results-oriented clinical leader looking to make a significant impact in a fast-paced, innovative environment, we invite you to apply for this transformative opportunity.
Key Responsibilities of VP, Clinical Operations with a Medical Device Company – Irvine, CA

Strategic Clinical Leadership: Develop, articulate, and execute the long-term global clinical development strategy in alignment with the company’s corporate objectives and product pipeline. Provide strategic input on product development plans, target product profiles, and go-to-market strategies. Represent the clinical department on the executive leadership team, providing critical insights and updates.
Operational Oversight and Execution: Assume ultimate responsibility for the planning, execution, and management of all clinical trials, from early feasibility and pivotal studies to post-market surveillance. Ensure studies are completed on schedule, within budget, and in full compliance with protocols and regulatory requirements. Implement best practices and innovative solutions to optimize trial efficiency and data quality.
Regulatory Compliance and Quality Assurance: Guarantee that all clinical activities adhere to the highest standards of Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements, including strict compliance with FDA regulations (e.g., 21 CFR Part 812, 50, 56) and international standards (e.g., ISO 14155, EU MDR). Oversee the preparation of clinical sections for regulatory submissions such as IDEs, PMAs, 510(k)s, and CE Mark technical files. Proactively manage clinical quality systems and prepare the department for internal and external audits.
Team Development and Mentorship: Lead, build, and mentor a high-performing clinical operations organization. Foster a collaborative, accountable, and patient-focused culture. Oversee resource planning, talent acquisition, professional development, and performance management for the entire clinical team, including Clinical Project Managers, CRAs, and Clinical Trial Assistants.
Cross-Functional Collaboration: Serve as a key collaborative partner to other functional leaders, including R&D, Regulatory Affairs, Quality Assurance, Biostatistics, Data Management, Marketing, and Sales. Ensure seamless communication and alignment on project timelines, goals, and challenges to facilitate successful product development and commercialization.
Vendor and Site Management: Direct the evaluation, selection, and management of Contract Research Organizations (CROs), central laboratories, and other clinical vendors. Establish and maintain strong, productive relationships with clinical investigative sites, principal investigators, and Key Opinion Leaders (KOLs) to ensure high levels of engagement and data quality.
Financial and Budgetary Management: Develop, manage, and maintain accountability for the multi-million dollar clinical operations budget. Provide accurate forecasting, tracking, and reporting of clinical study costs. Ensure prudent allocation of resources to achieve departmental and corporate goals efficiently.
Clinical Data and Publication Strategy: Oversee the processes for ensuring the integrity and quality of clinical trial data. Collaborate with medical affairs and biostatistics to support the analysis, interpretation, and reporting of clinical trial results. Contribute to the development of a strategic publication and presentation plan to disseminate clinical evidence to the scientific and medical communities.

Requirements for the VP, Clinical Operations with a Medical Device Company – Irvine, CA

Educational Background: An advanced degree (e.g., MS, PhD, MD, PharmD) in a relevant scientific or healthcare discipline is required.
Professional Experience: A minimum of 15 years of progressive experience in clinical research and operations within the medical device industry is essential. At least 7-10 years of this experience must be in a senior leadership capacity, with direct responsibility for managing teams, budgets, and clinical strategy.
Medical Device Expertise: Proven, extensive experience managing Class II and Class III medical device trials is mandatory. A deep and practical understanding of the entire product lifecycle, from concept through commercialization, is critical.
Regulatory Acumen: Expert-level knowledge of US and international medical device regulations, including FDA 21 CFR, IDE/PMA/510(k) processes, Good Clinical Practice (GCP), ISO 14155, and the EU Medical Device Regulation (MDR).
Leadership Skills: Demonstrated ability to lead, influence, and motivate a diverse team of professionals. Exceptional strategic thinking, critical analysis, and problem-solving skills. A track record of building and scaling high-performing clinical operations departments.
Communication and Interpersonal Skills: Superior verbal and written communication skills. The ability to articulate complex clinical and regulatory concepts to a wide range of audiences, from engineers to executive boards to regulatory authorities. Strong negotiation and relationship-building capabilities.
Business and Financial Acumen: Strong experience in developing and managing large, complex budgets. The ability to make sound financial decisions that align with strategic priorities. Experience in a fast-paced, venture-backed or publicly-traded company environment is highly desirable.
Location: Ability to work on-site at the company’s headquarters in Irvine, CA. Relocation assistance may be provided for an exceptional candidate.

Benefits & Perks Offered
Our client is committed to investing in their employees and offers a highly competitive and comprehensive compensation and benefits package, including:

Highly competitive base salary and an attractive executive-level annual bonus program.
Significant long-term incentive plan, including stock options or equity grants.
Comprehensive medical, dental, and vision insurance for employees and their dependents.
A robust 401(k) retirement savings plan with a generous company match.
Generous paid time off (PTO), including vacation, sick leave, and paid company holidays.
Company-paid life insurance, short-term, and long-term disability insurance.
Support for professional development, including attendance at conferences and continuing education courses.
A dynamic, innovative, and collaborative work environment with a strong company culture.
Potential for a comprehensive relocation package for qualified candidates.

How to Apply
This is an exclusive search conducted by JRG Partners. To be considered for this exceptional leadership opportunity, please submit your resume and a cover letter detailing your qualifications and interest in the role. We encourage you to highlight your specific experience in leading clinical operations for Class II/III medical device companies.
JRG Partners is a leader in executive search for the life sciences sector. To learn more about our expertise and other opportunities, please visit the JRG Partners’ Medical Device Practice page. We look forward to reviewing your application. Our client is an Equal Opportunity Employer.