VP Clinical Affairs

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.

Individual Qualifications

• 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.

Key Working Relationships

• 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

The Work Environment

• 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 is $300,000 to $350,000 and is bonus, equity / long-term incentive eligible.

Equal Opportunity

• QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic.