Global Medical Director - Atrial Fibrillation Solutions

Boston Scientific - Arden Hills, MN

Hybrid - Arden Hills, MN

Merchant Wholesalers, Durable Goods

About the position

Boston Scientific is seeking an experienced/practicing Cardiac Electrophysiologist looking to transition into the medical device industry. This Global Medical Director (GMD) position for our Rhythm Management Division (with focus on cardiac ablation therapies) is a key medical leadership role which offers the opportunity to leverage your therapeutic area expertise and procedural experience to support Boston Scientific's mission of developing and sustaining the best possible therapies and services for the patients we serve. The Global Medical Director acts as an advocate for the patient and a champion for the optimization of Boston Scientific's medical devices' safety throughout the product's lifecycle (pre-clinical, clinical and post-market), and a key subject matter expert involved in the development of multiple aspects of these technologies. This Global Medical Director will play a pivotal role in the constant evolution of Boston Scientific's Electrophysiology business and our Rhythm Management Portfolio in general. This position requires profound therapeutic area knowledge in cardiac electrophysiology, alongside substantial expertise in patient management and procedural skills. As part of our medical team, you will champion the advancement of safe devices by providing thoughtful medical oversight in close collaboration with cross-functional teams at every stage of development, clinical trials and once the devices are commercialized. A significant aspect of this role involves health risk assessment, considering risk-benefit balance, qualitative and quantitative application of scientific evidence and medical judgment. This Global Medical Director will also contribute to guiding the business strategy and drive innovation.

Responsibilities

• Act as an advocate for the patient and a champion for the optimization of Boston Scientific's medical devices' safety throughout the product's lifecycle.
• Provide thoughtful, evidence-based medical guidance, operational support, oversight, and therapeutic area expertise for a range of workstreams and internal customers encompassing the span of the entire product lifecycle as it relates to device safety and performance.
• Main spheres of activity include new product development and risk management, clinical trial safety and medical monitoring, post-market surveillance activities, assessment of device performance signals, and provision of general medical subject matter expertise.
• Engage on behalf of Boston Scientific in external interactions with study investigators, regulatory bodies, Key Opinion Leaders (KOLs), physician customers, professional societies, and advisory boards.
• Interact with independent committees such as clinical event committees (CEC) and data monitoring committees (DMC), ensuring that the exchange of information is transparent and adequate to meet objectives of safety oversight.
• Provide operational support and oversight to teams regarding clinical trial planning, clinical protocol development, investigator selection, training of internal and external personnel, medical monitoring for patient safety and trial conduct, individual and aggregate clinical trial safety review, data analysis and interpretation, quality control, and presentation/publication.
• Provide specialized therapeutic area expertise throughout the device life cycle, including medical input into risk management, Clinical Evidence Reports (CERs), Summaries of Safety and Clinical Performance, product complaints, vigilance reports, health risk assessments, field safety communications, and serves as a medical advisor for regulatory issues and in the creation of instructional material/labeling to ensure safe use of Boston Scientific's medical devices.
• Provide direct medical input into post-market trending and safety signal detection, assessment, management and reporting.
• Monitor and assess adverse events to determine the escalation of safety issues for communication and action to senior leadership.
• Provide independent review, authorship, and approval of a range of clinical, scientific and safety reports used for safety and performance assessment in various quality, risk management, clinical trial and clinical evidence processes for risk management, post-market surveillance and regulatory submission.
• Review and approval of educational and promotional materials.
• Contribute to internal development and assessment of novel technologies, provides strategic input for business development teams, and provides medical evaluation in due diligence and operational support for integration of acquired technologies.
• Contribute to training and mentorship of medical and non-medical personnel within the division who have safety-focused or adjacent roles.

Requirements

• Minimum of 5 years of clinical experience in the practice of cardiac electrophysiology in a clinical environment managing patients and performing complex cardiac electrophysiology procedures.
• Expert knowledge of and experience in medical and interventional management of complex cardiac arrhythmias.
• Demonstrated leadership responsibilities and strong interpersonal skills with experience working effectively in a team/matrix environment.
• Strong analytical skills and attention to detail.
• Excellent communication skills (written and verbal).
• Ability to assertively convey complex medical concepts to a wide audience both internal and external to the company, across multiple levels of seniority, through formal and informal presentations and written reports.
• General, working knowledge of the regulations and standard practices governing clinical research.
• General, working knowledge of clinical statistical principles.
• General, working knowledge of Good Clinical Practice concepts.

Nice-to-haves

• Direct Transition from Clinical Practice to the Industry.
• Global experience or knowledge of the practice of Cardiac Electrophysiology.
• Past experience as a medical advisor for a medical device company.
• Prior experience as a clinical investigator in a medical device clinical research study and/or member of an Institutional Review Board.
• Experience applying principles of risk management.
• A general, working knowledge of applicable global medical device regulations.