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Overview

Company
QuidelOrtho
Location
all cities, OH 36
Employment type
On-site
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Back to Jobs
Q
QuidelOrthoVerified Employer

Business Services & Consulting • all cities, OH 36

VP Clinical Affairs (36)

all cities, OH 36On-sitePosted 10 hours ago
Business Services & Consulting

About the Role

Vice President Of Clinical Affairs

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.

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.
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 Work Environment

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. 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.

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.QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related duties.

If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

Vice President Of Clinical Affairs

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.

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.
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 Work Environment

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. 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.

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.QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related duties.

If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

What You'll Do

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.

Skills & Technologies

Business Services & Consulting

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