- As an active member of and leader within a cross-functional team comprising medical safety, clinical product risk, and biostatistical analytics, the MDMS exhibits high levels of ethics and accountability and acts as a key advocate for the function of medical safety to influence internal and external stakeholders in matters of medical device safety.
- Provides detailed medical safety 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, and provision of general medical subject matter expertise. Supported teams include clinical trials, clinical evidence, quality, R&D, regulatory, 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, KOLs, physician customers, professional societies and advisory boards on matters of device performance and medical safety. Interacts with independent committees such as clinical event committees and data monitoring committees, 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, 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, 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 HCPs to help assess significant adverse events. Advises on failure investigations and provides medical opinion 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.
What we’re looking for in you:
- Minimum of 5 years of clinical experience in the practice of cardiac electrophysiology, OR 7 years of combined clinical/industry work experience within a life sciences company and clinical environment performing procedures using cardiac rhythm management/electrophysiology devices.
- MD degree (or accepted international equivalent) is required.
- Must be a cardiologist with formal subspecialty training in clinical cardiac electrophysiology.
- Must be either ABIM Board Certified or Eligible in Clinical Cardiac Electrophysiology, or possess equivalent specialty certification from an applicable international body.
- Must hold a valid, unrestricted and unchallenged license to practice medicine.
- Expert knowledge of and experience in implanting and managing medical devices relating to the diagnosis and treatment of cardiac arrhythmias, sudden death, and heart failure
- Strong analytical skills and attention to detail.
- Excellent communication skills (written and verbal).
- Ability to 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.
- Strong interpersonal skills and experience working effectively in a team/matrix environment.
- General, working knowledge of the regulations and standard practices governing clinical research.
- General, working knowledge of clinical statistical principles.
- Past experience within a medical device company in one of the following functions: medical safety, medical affairs, clinical trials, R&D, quality, or regulatory.
- Prior experience as a clinical investigator in a medical device clinical research study.
- Experience applying principles of risk management.
- A general, working knowledge of applicable global medical device regulations.