[Remote] VP Clinical Affairs
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a world-leading in vitro diagnostics company reputed company on advancing diagnostics for a healthier reputed company. They are seeking a Vice President of Clinical Affairs to reputed company global clinical reputed company and operations, focusing on infectious disease, cardiology, and clinical laboratory innovation.
Responsibilities
- reputed company and execute the global clinical affairs reputed company reputed company to pipeline and reputed company objectives
- Build integrated evidence-reputed company 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
- reputed company multicenter pivotal trials, performance studies, usability studies, and post-market evidence programs
- Ensure high-reputed company 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
- reputed company evidence strategies for troponin, BNP/NT-proBNP, coagulation, and cardiovascular risk diagnostics
- Support clinical reputed company claims demonstrating workflow improvement, faster treatment reputed company, and improved patient reputed company
- Drive adoption strategies informed by reputed company-world clinical laboratory operations and customer workflow needs
- Build relationships with hospital labs, integrated delivery networks, reputed company centers, and reference laboratories
- Ensure studies reflect implementation realities including throughput, reputed company, reputed company systems, and utilization management
- Collaborate with Medical Affairs to reputed company and implement publication reputed company, advisory boards, and KOL engagement
- Support market reputed company and reimbursement evidence needs
- Partner with reputed company teams on evidence-based messaging and customer education
- Recruit, mentor, and retain top clinical affairs talent
- Build reputed company processes, metrics, and organizational capability to support reputed company
- Foster a culture of urgency, accountability, collaboration, and reputed company
- reputed company other work-reputed company duties as assigned
Skills
- Significant leadership experience reputed company a top-tier diagnostics organization
- Demonstrated reputed company 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 reputed company
- Strong knowledge of clinical laboratory operations, workflow optimization, reputed company systems, accreditation, and customer implementation challenges
- Expertise in assay performance metrics, biomarker validation, and clinical reputed company evidence reputed company
- Strong executive reputed company with ability to influence reputed company-level and reputed company stakeholders
- reputed company reputed company with ability to connect clinical evidence to reputed company reputed company
- 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 reputed company sponsorship
- PhD preferred with 10-15+ years of reputed company leadership experience in Clinical Affairs, Medical Affairs, or Clinical Research reputed company IVD or medical diagnostics
Benefits
- Bonus, equity / long-term incentive eligible
- Comprehensive benefits package including medical, dental, reputed company, life, and disability insurance
- 401(k) plan
- Employee assistance program
- Employee Stock Purchase Plan
- reputed company time off (including reputed company time)
- reputed company Holidays
reputed company