Boston Scientific

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.. 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.. 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 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.

global medical director

Job Number: 650 External Description: Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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: Boston Scientific is seeking an experienced Cardiac Electrophysiologist looking to transition into the medical device industry. This Global Medical Director (GMD) position for our Rhythm Management Division (with focus on our Cardiac Diagnostic Therapies and Services) 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. This Global Medical Director acts as an advocate for the patient and a champion for the optimization of medical device 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 shaping Boston Scientific's Cardiac Diagnostics Services 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 and services and ensure the effective communication of their benefits and risks in a thorough and pertinent manner. This also involves qualitative and quantitative application of scientific evidence and medical analysis to promote patient safety, balance risk with benefit, guide strategy, and drive innovation. This key medical leadership role carries responsibility for ensuring that rigorous, proactive medical input is provided across all areas of the business and serves as the voice of the physician and patient in the clinical study and commercial application of our technologies. The ultimate goal of this role is to safeguard at all times patient safety. . The Global Medical Director works in a collegial, collaborative environment with medical colleagues within the team, division and cross-divisionally; and partners closely with cross-functional partners to deliver the best possible quality to Boston Scientific patients. Your responsibilities will include: <ul> <li>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.</li> <li>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. </li> <li>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.</li> <li>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. </li> <li>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.</li> <li>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.</li> <li>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. </li> <li>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.</li> <li>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.</li> <li>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. </li> <li>Contributes to training and mentorship of medical and non-medical personnel within the division who have safety-focused or adjacent roles.</li></ul>Required qualifications: <ul> <li>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. </li> <li>Expert knowledge of and experience in medical and interventional management of complex cardiac arrhythmias.</li> <li>Demonstrated leadership responsibilities and strong interpersonal skills with experience working effectively in a team/matrix environment. </li> <li>Strong analytical skills and attention to detail.</li> <li>Excellent communication skills (written and verbal).</li> <li>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.</li> <li>General, working knowledge of the regulations and standard practices governing clinical research.</li> <li>General, working knowledge of clinical statistical principles.</li> <li>General, working knowledge of Good Clinical Practice concepts.</li></ul>Required education and credentials: <ul> <li>Medical Doctor (MD) degree (or accepted international equivalent) is required. </li> <li>The candidate must be a cardiologist with formal subspecialty training in clinical cardiac electrophysiology.</li> <li>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.</li> <li>The candidate must hold a valid, unrestricted and unchallenged license to practice medicine, and be in good standing with the licensing body. </li></ul>Preferred qualifications: <ul> <li>Direct Transition from Clinical Practice to the Industry.</li> <li>Global experience or knowledge of the practice of Cardiac Electrophysiology.</li> <li>Past experience as a medical advisor for a medical device company.</li> <li>Prior experience as a clinical investigator in a medical device clinical research study and/or member of an Institutional Review Board.</li> <li>Experience applying principles of risk management.</li> <li>A general, working knowledge of applicable global medical device regulations.</li></ul>Requisition ID: 579121 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 prohibited substance 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. 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. RSRBSC Nearest Major Market: Minneapolis Job Segment: Clinical Research, Medical Research, Medical Device, Risk Management, PLM, Healthcare, Finance, Management Job Number: 579121 Community / Marketing Title: Global Medical Director - Atrial Fibrillation Solutions & Cardiac Rhythm Management/Diagnostics Location_formattedLocationLong: Arden Hills, Minnesota US

START NEW SEARCH