Global Medical Director-Watchman and Electrophysiology
Core
Provide medical expertise and strategic guidance across the lifecycle of electrophysiology and left atrial appendage closure (LAAC) therapies.
Role type
Global Medical Director (Cardiac Electrophysiology)
Builds
Electrophysiology and LAAC therapies
Domain
Medical Devices / Cardiology
Deliverable
client delivery
Required skills
Cardiac electrophysiology, complex arrhythmia management, clinical trial design, Good Clinical Practice (GCP), medical device development, benefit-risk assessment, regulatory affairs, post-market surveillance
Preferred skills
Clinical investigator experience, Institutional Review Board (IRB) participation, global medical device regulations knowledge
Technologies
None stated
Responsibilities
Serve as a medical expert and patient advocate for electrophysiology and LAAC therapies throughout the product lifecycle; Provide medical leadership and benefit-risk assessment across product development, clinical studies and post-market activities; Partner with Clinical Research, Clinical Evidence, Quality, Regulatory Affairs, R&D, Marketing and Business Development teams to support product strategy and medical decision-making; Provide medical oversight for clinical trials, including protocol development, investigator engagement, patient safety monitoring, data interpretation and scientific dissemination; Support post-market surveillance activities, including safety signal evaluation, device performance assessment and health risk analysis; Collaborate with health care providers, investigators and internal teams to assess significant adverse events and emerging clinical concerns; Represent Boston Scientific with key opinion leaders, regulatory authorities, advisory boards and professional societies; Review and approve clinical, scientific and regulatory documents, including clinical evidence reports, safety communications and risk management materials; Provide medical review of scientific, educational and promotional content to ensure clinical accuracy and compliance; Contribute clinical expertise to innovation initiatives, product development activities, business development evaluations and due diligence efforts; Support training, mentorship and development of medical and cross-functional teams.