VP Clinical Affairs

QuidelOrtho•San Diego, CA

2d•$300,000 - $350,000•Remote

About The Position

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. We are seeking an accomplished and visionary Vice President of Clinical Affairs to lead the global clinical strategy and operations department for a rapidly growing diagnostics company focused on infectious disease, cardiology, and clinical laboratory innovation. This is a high-impact executive opportunity for a leader who has helped scale and commercialize successful IVD platforms and who is ready to shape the next generation of diagnostics. The Vice President of Clinical Affairs will lead all Clinical Strategy and Clinical Operations across the enterprise. They will be responsible for evidence generation and study execution across the company’s infectious disease, cardiology, clinical laboratory portfolio, including molecular diagnostics, immunoassays, biomarkers, rapid testing, and point-of-care platforms. The ideal candidate will bring experience from a leading diagnostics organization and have a track record of creating and executing clinical evidence programs that resulted in regulatory approvals, market adoption, and commercial success. This role offers the chance to build strategy, influence enterprise direction, lead a high-performing organization, and bring meaningful diagnostic innovations to clinicians, laboratories, and patients worldwide.

Requirements

PhD preferred with 10-15+ years of progressive leadership experience in Clinical Affairs, Medical Affairs, or Clinical Research within IVD or medical diagnostics.
Significant leadership experience within a top-tier diagnostics organization.
Demonstrated success leading studies supporting major product launches and regulatory approvals.
Experience across infectious disease, immunoassay, molecular diagnostics, cardiology, and/or core laboratory platforms.
Proven people leadership with experience managing global teams and external partners.
Deep understanding of FDA, IVDR, CLIA, CAP, GCP, and global diagnostics pathways.
Strong knowledge of clinical laboratory operations, workflow optimization, quality systems, accreditation, and customer implementation challenges.
Expertise in assay performance metrics, biomarker validation, and clinical utility evidence generation.
Strong executive presence with ability to influence board-level and enterprise stakeholders.
Commercial mindset with ability to connect clinical evidence to growth outcomes.
Entrepreneurial leader who thrives in a fast-paced, high-accountability environment.

Responsibilities

Develop and execute the global clinical affairs strategy aligned to pipeline and growth objectives.
Build integrated evidence-generation plans supporting FDA, IVDR, CE Mark, and international submissions.
Serve as a trusted executive advisor on clinical trends, competitive dynamics, and market opportunities.
Translate unmet customer needs from health systems, laboratories, and clinicians into actionable clinical priorities.
Lead multicenter pivotal trials, performance studies, usability studies, and post-market evidence programs.
Ensure high-quality execution across timelines, budgets, CRO management, and investigator relationships.
Interpret clinical data to support claims development, product positioning, and launch readiness.
Advance programs in respiratory disease, sepsis, bloodstream infection, antimicrobial stewardship, and emerging pathogens.
Lead evidence strategies for troponin, BNP/NT-proBNP, coagulation, and cardiovascular risk diagnostics.
Support clinical utility claims demonstrating workflow improvement, faster treatment decisions, and improved patient outcomes.
Drive adoption strategies informed by real-world clinical laboratory operations and customer workflow needs.
Build relationships with hospital labs, integrated delivery networks, academic centers, and reference laboratories.
Ensure studies reflect implementation realities including throughput, staffing, quality systems, and utilization management.
Collaborate with Medical Affairs to develop and implement publication strategy, advisory boards, and KOL engagement.
Support market access and reimbursement evidence needs.
Partner with Commercial teams on evidence-based messaging and customer education.
Recruit, mentor, and retain top clinical affairs talent.
Build scalable processes, metrics, and organizational capability to support growth.
Foster a culture of urgency, accountability, collaboration, and excellence.
Perform other work-related duties as assigned.