Newport Beach, California, United States
Medical Affairs Leader | Cardiovascular & Venous Therapies | Innovation & Strategy I am a Medical Affairs leader specialising in cardiovascular and venous therapies, with expertise in clinical development, evidence generation, regulatory strategy, and health economics. With a background in academic vascular surgery, translational research, and medical technology innovation, I work at the intersection of clinical practice, regulatory affairs, and business strategy to advance patient-centered medical solutions. Currently, I serve as an Advanced Venous Therapies Innovation Fellow at Inari Medical, where I lead cross-functional initiatives in medical affairs, clinical development, and market access strategies to drive the adoption of innovative cardiovascular and venous treatment solutions. My expertise spans clinical research, KOL engagement, post-market surveillance, regulatory affairs, and real-world evidence generation, ensuring regulatory compliance and commercial success of novel therapies. Previously, I held leadership roles in quality improvement and healthcare strategy at HCA Healthcare UK, where I developed and implemented performance improvement strategies across private and public sectors. My background in academic research and health technology development positions me to bridge scientific innovation with industry-driven strategies. I am also pursuing an MBA at Imperial College Business School, strengthening my expertise in business strategy, market access, and commercialization of medical technologies. My goal is to lead medical affairs strategy for cardiovascular and venous therapies, ensuring evidence-based innovations that improve patient outcomes and healthcare delivery. Key Expertise: Medical Affairs | Cardiovascular & Venous Therapies | Clinical Development | Regulatory Strategy (FDA, MDR) | Health Economics & Market Access (HEOR) | KOL Engagement | Real-World Evidence | Medical Device Innovation | Business Strategy in MedTech https://www.researchgate.net/profile/Adam_Gwozdz https://www.imperial.ac.uk/people/a.gwozdz
- Led clinical research on venous thromboembolism (VTE), in-stent thrombosis, and biomarker discovery for advanced venous disease therapies. - Developed standardized outcome measures and evidence-based protocols to improve patient care in venous disorders. - Partnered with industry and regulatory agencies to facilitate clinical trials and real-world evidence studies.
- Provide strategic direction in medical affairs and regulatory planning for wearable technology and remote patient monitoring solutions. - Support business development, clinical validation, and commercialization efforts to bring digital health innovations to market.
Stryker acquired Inari Medical in Feb 2025 for $4.9B. - Drive medical affairs strategy for venous therapies, supporting clinical development, regulatory compliance, and real-world evidence generation. - Collaborate with R&D, regulatory, and clinical affairs teams to generate scientific evidence supporting new product development and market access. - Engage with key opinion leaders (KOLs), healthcare professionals, and industry stakeholders to support the adoption of advanced venous therapies. - Oversee post-market surveillance, medical safety, and quality assurance to ensure regulatory compliance and patient safety. - Drive scientific communication, medical education, and conference presentations, positioning Inari as a leader in venous disease innovation.
- Designed and implemented clinical quality improvement initiatives across cardiovascular and surgical specialties. - Led data-driven medical safety and regulatory compliance programs, improving patient outcomes and hospital performance. - Collaborated with multidisciplinary teams to enhance clinical governance, risk management, and healthcare efficiency. - Line managed 30+ doctors across medical, surgical and intensive care service lines.