The Role

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.

Location: This role may be performed remotely, with a preference for candidates located near our offices in San Diego, CA; Raritan, NJ; or Rochester, NY.

The Responsibilities:

Strategic Leadership

• 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.

Clinical Program Leadership

• 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.

Infectious Disease & Cardiology Focus

• 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.

Clinical Laboratory Partnership

• 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.

Scientific & Commercial Impact

• 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.

Team Leadership

• 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.

The Individual

• 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.
• Travel up to 30-40% visiting QO's design centers and supporting clinical trials
• This position is not currently eligible for visa sponsorship.

The Key Working Relationships

Internal Partners:

• R&D, Regulatory Affairs, Quality, Medical Affairs, Market Access, and Commercial teams to accelerate product development and successful global launches

External Partners:

• Vendors and suppliers

How We Work

At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together - Collaborate intentionally, grow as a team
• Make It Happen - Focus on priorities, embrace continuous improvement
• Commit to Service - Cultivate a service mindset
• Embrace Inclusion - Be open and authentic, welcome diverse perspectives

The Work Environment

If the work environment is mainly typically in the lab/warehouse/production line, use verbiage like:

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines. Travel includes airplane, automobile travel and overnight hotel; up to 30-40% domestically.

Physical Demands

No strenuous physical activity required. Occasional light lifting of materials may be needed. Substantial time will be spent in virtual or in-person meetings, engaging with customers, and working on scientific content and documentation.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $300,000 to $350,000 and is bonus, equity / long-term incentive eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

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