Boston Scientific Global Medical Director - Atrial Fibrillation 

United States, Minnesota, Arden Hills 

846019365

US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove

Your responsibilities will include:

• As an active member of and leader within a medical and patient safety team comprising medical, patient safety, clinical trials operations safety and cardiac diagnostics services, the GMD exhibits high levels of ethics and accountability and acts as a key advocate for our function to influence internal and external stakeholders in matters of medical device safety.
• Provides thorough/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. Supported teams include clinical trials, clinical evidence, quality, Research and Development (R&D), regulatory affairs, post-market surveillance, marketing, business development, and other functional units.
• Engages compliantly on behalf of Boston Scientific in external interactions with study investigators, regulatory bodies, Key Opinion Leaders (KOLs), physician customers, professional societies and advisory boards on matters of device performance, medical safety and medical matters in general as they relate to the therapies and services provided by Boston Scientific. Interacts with independent committees such as clinical event committees (CEC) and data monitoring committees (DMC), ensuring exchange of information with these committees is transparent and adequate to meet objectives of safety oversight.
• Provides hands-on 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.
• Provides 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 medical devices.
• Provides direct medical input into post-market trending and safety signal detection, assessment, management and reporting. Liaises with Boston Scientific field personnel and Health Care Providers (HCPs) to help assess significant adverse events. Advises on failure investigations and provides medical guidance in assessing health hazards posed by device failure. Implements experience-based understanding of medical risk and benefit to arrive at objective assessments of health risk.
• Monitors and assesses adverse events to determine the escalation of safety issues for communication and action to senior leadership. Regularly interacts with senior management concerning significant and emerging safety matters.
• Provides 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.
• Reviews and approves educational and promotional materials. Also reviews and edits clinical trial protocols to ensure accuracy, consistency with standard of care and relevant safety standards and regulations, logistical ease, and internal consistency with BSC Quality Policies.
• Contributes 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. Plays a key role in the integration of acquired technologies (including processes and clinical trials) into Boston Scientific Rhythm Management.
• Contributes to training and mentorship of medical and non-medical personnel within the division who have safety-focused or adjacent roles.

Required qualifications:

• 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.

Required education and credentials:

• Medical Doctor (MD) degree (or accepted international equivalent) is required.
• The candidate must be a cardiologist with formal subspecialty training in clinical cardiac electrophysiology.
• The candidate must be either ABIM Board Certified or Eligible in Clinical Cardiac Electrophysiology or possess equivalent specialty certification from a relevant international body, as applicable.
• The candidate must hold a valid, unrestricted and unchallenged license to practice medicine, and be in good standing with the licensing body.

Preferred qualifications:

• 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.