Note: The job is a remote job and is open to candidates in USA. QuidelOrtho is a world-leading in vitro diagnostics company focused on advancing diagnostics for a healthier future. They are seeking a Vice President of Clinical Affairs to lead global clinical strategy and operations, focusing on infectious disease, cardiology, and clinical laboratory innovation.
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
Skills
- 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
- Travel up to 30-40% visiting QO's design centers and supporting clinical trials
- This position is not currently eligible for visa sponsorship
- PhD preferred with 10-15+ years of progressive leadership experience in Clinical Affairs, Medical Affairs, or Clinical Research within IVD or medical diagnostics
Benefits
- Bonus, equity / long-term incentive eligible
- Comprehensive benefits package including medical, dental, vision, life, and disability insurance
- 401(k) plan
- Employee assistance program
- Employee Stock Purchase Plan
- Paid time off (including sick time)
- Paid Holidays
Company Overview