Role Overview for VP, Clinical Operations with a Diagnostics Company – Irvine, CA
JRG Partners is proud to represent a pioneering diagnostics company at the forefront of medical innovation. Located in the vibrant biotechnology hub of Irvine, California, our client is dedicated to developing and commercializing groundbreaking diagnostic solutions that empower clinicians and improve patient outcomes worldwide. They are currently seeking a visionary and strategic Vice President of Clinical Operations to join their executive leadership team. This is a pivotal role responsible for providing the leadership, direction, and management for all aspects of the company’s clinical operations.
The VP of Clinical Operations will be the architect of the clinical evidence strategy, building and leading a world-class team to execute clinical trials with precision, efficiency, and the highest standards of quality and compliance. This individual will be instrumental in guiding novel diagnostic products from concept through to regulatory approval and market launch. The ideal candidate is a seasoned leader with an extensive background in the In Vitro Diagnostics (IVD) or medical device industry, possessing a deep understanding of the global regulatory landscape and a proven track record of successfully managing complex clinical programs.
You will be responsible for ensuring that all clinical studies are designed and conducted to meet corporate objectives, on schedule, and within budget, while ensuring complete adherence to Good Clinical Practice (GCP) and other regulatory requirements. This role offers a unique opportunity to make a significant impact on the company’s growth trajectory and to contribute to the advancement of modern medicine.
As a key member of the executive team, you will collaborate extensively with R&D, Regulatory Affairs, Quality Assurance, Medical Affairs, and Commercial departments to ensure seamless integration of clinical strategy with the broader business goals. Your leadership will foster a culture of accountability, innovation, and operational excellence within the clinical operations department. If you are a strategic thinker with a passion for building high-performing teams and a desire to shape the future of diagnostics, we invite you to explore this exceptional opportunity.
Key Responsibilities of VP, Clinical Operations with a Diagnostics Company – Irvine, CA
The Vice President of Clinical Operations will have a broad range of responsibilities, encompassing strategic planning, tactical execution, team leadership, and cross-functional collaboration. Success in this role requires a hands-on yet strategic approach to managing the entire clinical trial lifecycle.
Strategic Leadership and Planning
Develop and execute the long-term clinical strategy in alignment with the company’s product pipeline and corporate objectives. Provide expert clinical input to the executive team for strategic planning, portfolio management, and business development initiatives. Proactively identify and mitigate risks associated with clinical programs.
Clinical Program Oversight
Assume ultimate accountability for the planning, execution, and reporting of all clinical trials, including feasibility, pivotal, and post-market studies. Ensure that trials are conducted on time, within budget, and in full compliance with approved protocols and regulatory standards.
Regulatory Compliance and Quality
Guarantee that all clinical activities adhere to the highest standards of quality and are conducted in accordance with Good Clinical Practice (GCP), ICH guidelines, and other applicable global regulations. You will be the internal subject matter expert on the comprehensive FDA regulations for In Vitro Diagnostics (IVDs), CE-IVDR, and other international requirements. Prepare and lead the clinical team for regulatory inspections and audits.
Team Development and Mentorship
Recruit, train, mentor, and lead a high-performing clinical operations team. Foster a collaborative, results-oriented, and positive work environment. Establish clear goals and performance metrics for the department and individual team members, promoting professional growth and development.
Vendor and Site Management
Lead the evaluation, selection, and management of Contract Research Organizations (CROs), central laboratories, and other clinical vendors. Oversee the identification, qualification, and management of clinical trial sites, building strong relationships with principal investigators and site staff to ensure high-quality data and efficient trial execution.
Budget and Resource Management
Develop, manage, and forecast the annual clinical operations budget. Ensure prudent fiscal management of all clinical programs and departmental expenses. Effectively allocate internal and external resources to meet program timelines and corporate goals.
Cross-Functional Collaboration
Serve as the primary clinical operations liaison with internal stakeholders, including R&D, Regulatory Affairs, Quality, Biostatistics, Data Management, and Commercial teams. Ensure effective communication and alignment across all functions to support successful product development and launch.
Clinical Data and Reporting
Oversee the processes for clinical data collection, management, and analysis, ensuring data integrity and accuracy. Supervise the preparation of clinical study reports (CSRs), scientific publications, and the clinical sections of regulatory submissions (e.g., IDE, 510(k), PMA, De Novo).
Requirements for the VP, Clinical Operations with a Diagnostics Company – Irvine, CA
We are seeking a highly qualified and experienced professional who meets the following criteria:
Education
An advanced degree (M.S., Ph.D., M.D., or Pharm.D.) in a relevant scientific or clinical field is strongly preferred. A Bachelor’s degree with extensive, directly relevant experience will be considered.
Experience
A minimum of 15 years of progressive experience in clinical operations or clinical development within the diagnostics (IVD), medical device, or biopharmaceutical industry. A minimum of 8-10 years of experience in a leadership role with direct management of clinical teams is required.
IVD Expertise
Demonstrated, in-depth experience managing clinical trials for In Vitro Diagnostic (IVD) products is essential. Experience with various diagnostic platforms (e.g., molecular diagnostics, immunoassays, clinical chemistry) is highly desirable.
Regulatory Knowledge
Expert-level understanding of the global regulatory environment for diagnostics, including FDA regulations (21 CFR Part 812, 820), GCP, ICH guidelines, and international standards such as ISO 14155 and the EU IVDR. Proven experience interacting with regulatory agencies is required.
Leadership Skills
Exceptional leadership, team-building, and interpersonal skills. A proven ability to inspire and motivate teams, manage performance, and develop talent. Experience scaling a clinical operations function to meet the demands of a growing organization.
Strategic and Analytical Acumen
Strong strategic thinking and problem-solving skills. The ability to translate corporate goals into actionable clinical plans and to make data-driven decisions in a fast-paced environment.
Communication Skills
Outstanding written and verbal communication skills. The ability to effectively present complex information to diverse audiences, including executive leadership, scientific advisory boards, and regulatory authorities.
Project and Financial Management
Proven ability to manage multiple complex projects simultaneously. Strong financial acumen with experience developing and managing significant departmental and clinical trial budgets.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package. They believe in investing in their employees’ health, well-being, and professional growth.
Competitive Compensation
A highly attractive base salary complemented by a significant annual performance-based bonus.
Equity Participation
Meaningful stock options or equity grants, allowing you to share in the long-term success of the company.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents, with a significant portion of the premiums covered by the company.
Retirement Savings
A 401(k) plan with a generous company match to help you plan for your future.
Generous Paid Time Off
A flexible and generous paid time off (PTO) policy, in addition to paid company holidays, to support a healthy work-life balance.
Professional Development
A strong commitment to your career growth with opportunities for continued education, conference attendance, and leadership training.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates.
Inspiring Work Environment
A collaborative, innovative, and mission-driven culture located in a state-of-the-art facility in Irvine, CA.
How to Apply
This is a retained search being conducted exclusively by JRG Partners. If you are a dynamic and experienced clinical operations leader with a passion for advancing diagnostic technology, we encourage you to apply for this exciting opportunity.
To be considered, please submit your resume and a cover letter detailing your qualifications and interest in the role. All applications will be treated with the strictest confidence. Our team will review your submission and contact qualified candidates for further discussion. For more information about our expertise in this sector, please visit the JRG Partners’ Life Sciences practice page. We look forward to connecting with you and exploring how your experience can help shape the future of our client’s success.
