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Medical Director, Medical Safety (MDMS) - EP Job

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Date: Sep 1, 2021

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

Additional Locations: , Remote


Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.


About the role:
The Medical Director, Medical Safety (MDMS) for EP (with focus on Pulsed Field Ablation) is an advocate for the patient and a champion for the optimization of medical device safety throughout the product’s lifecycle, and a key subject matter expert involved in the development of multiple aspects of these technologies. This role leverages deep therapeutic area expertise in the field of cardiac ablation, coupled with extensive procedural experience, to promote the development of safe devices and the clear articulation of benefit and risk in a comprehensive and relevant manner. This key medical leadership role carries responsibility for ensuring that rigorous, proactive medical safety input is provided across all areas of the business and serves as the voice of the physician and patient in the critical evaluation of safety. The MDMS helps shape and influence the development of safe medical devices by qualitative and quantitative application of scientific and medical analysis to promote patient safety, balance risk with benefit, guide strategy, and drive innovation. 


Your responsibilities will include:

  • 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, assessment of device performance signals, 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. Plays a key role in the integration of acquired technologies (including processes and clinical trials) into Boston Scientific Rhythm Management. 


Required qualifications:

  • MD degree (or accepted international equivalent) is required
  • Experience as a Cardiologist with formal subspecialty training in clinical cardiac electrophysiology
  • ABIM Board Certified or Eligible in Clinical Cardiac Electrophysiology or possess equivalent specialty certification from an applicable international body, as applicable
  • Must hold a valid, unrestricted and unchallenged license to practice medicine, and be in good standing with the licensing body
  • 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 complex cardiac ablation procedures
  • Expert knowledge of and experience in medical and interventional management of left atrial cardiac arrhythmias, including experience with “single shot” modalities, e.g., cryoablation balloon therapies
  • Leadership experience working effectively in a team/matrix environment
  • Knowledge of clinical statistical principles
  • 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
  • Knowledge of the regulations and standard practices governing clinical research
  • Professional communication skills (written and verbal)

Preferred qualifications:

  • Strong analytical skills and attention to detail
  • Past experience within a medical device company in one of the following functions: medical safety, medical affairs, clinical trials, R&D, quality, or regulatory
  • Experience in a blended company comprised of legacy and acquired entities
  • Prior experience as a clinical investigator in a medical device clinical research study
  • Experience applying principles of risk management
  • Knowledge of applicable global medical device regulations



Requisition ID: 502766


As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.


So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.


Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


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