VP Clinical Affairs

Role Overview

• 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
• 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
• 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

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

Tech Stack

• Google Cloud Platform

Benefits

• 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