VP Clinical Affairs

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Develop and implement a comprehensive global clinical affairs strategy that aligns with pipeline and growth objectives.

• Create integrated evidence-generation plans that support FDA, IVDR, CE Mark, and international submissions.

• Act as a reliable executive advisor on clinical trends, competitive dynamics, and market opportunities.

• Convert unmet customer needs from healthcare systems, laboratories, and clinicians into actionable clinical priorities.

• Oversee multicenter pivotal trials, performance studies, usability studies, and post-market evidence programs.

• Ensure the high-quality execution of timelines, budgets, CRO management, and investigator relationships.

• Analyze clinical data to support claims development, product positioning, and readiness for launch.

• Advance programs related to respiratory diseases, sepsis, bloodstream infections, antimicrobial stewardship, and emerging pathogens.

• Lead evidence strategies for troponin, BNP/NT-proBNP, coagulation, and cardiovascular risk diagnostics.

• Drive adoption strategies that are informed by real-world clinical laboratory operations and customer workflow requirements.

• Cultivate relationships with hospital laboratories, integrated delivery networks, academic institutions, and reference laboratories.

• Collaborate with Medical Affairs to develop and execute publication strategies, advisory boards, and KOL engagement.

• Address market access and reimbursement evidence requirements.

• Partner with Commercial teams to create evidence-based messaging and customer education initiatives.

• Recruit, mentor, and retain top talent in clinical affairs.

• Establish scalable processes, metrics, and organizational capabilities to facilitate growth.

• Promote 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 in a top-tier diagnostics organization.

• Proven success in leading studies that support major product launches and regulatory approvals.

• Experience in infectious disease, immunoassay, molecular diagnostics, cardiology, and/or core laboratory platforms.

• Demonstrated people leadership with experience managing global teams and external partners.

• Extensive 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 the ability to influence board-level and enterprise stakeholders.

• Commercial mindset with the ability to link clinical evidence to growth outcomes.

• Entrepreneurial leader who thrives in a dynamic, high-accountability environment.

🏝️ 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.