Medical Director, Medical Safety (MDMS) - Neuromodulation

divh2Medical Director, Medical Safety (MDMS) for Neuromodulation/h2pAt Boston Scientific, well give you the opportunity to harness all thats 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, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions./ppThe medical director, medical safety (MDMS) for Neuromodulation is an advocate for the patient and a champion for optimizing medical device safety throughout the product lifecycle. This role serves as a key subject matter expert supporting multiple aspects of technology development. Leveraging deep therapeutic expertise in deep brain stimulation and pain management, along with extensive procedural experience, the MDMS promotes the development of safe devices and ensures clear articulation of benefit and risk in a comprehensive and relevant manner./ppThis medical leadership role is responsible for providing rigorous, proactive medical safety input across the business and serves as the voice of the physician and patient in evaluating safety. The MDMS applies qualitative and quantitative scientific and medical analysis to promote patient safety, balance risk and benefit, guide strategy and drive innovation./ppThis role is designated as remote, allowing employees to work from a home-based office. Candidates must reside within the United States and be able to travel as business needs require. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time./ppServe as a leader within a cross-functional team spanning medical safety, clinical product risk and biostatistical analytics, demonstrating high ethical standards and accountability while advocating for medical safety across internal and external stakeholders./ppProvide medical safety guidance, operational support and therapeutic expertise across the product lifecycle, including new product development, risk management, clinical trial safety and medical monitoring, post-market surveillance and device performance evaluation./ppCollaborate with internal partners including clinical, clinical evidence, quality, research and development, regulatory, post-market surveillance, marketing and business development to ensure comprehensive safety oversight./ppEngage on behalf of Boston Scientific with investigators, regulatory bodies, key opinion leaders, physician customers, professional societies and advisory boards on matters of device performance and medical safety./ppInteract with independent committees, including clinical event committees and data monitoring committees, ensuring transparent and effective exchange of safety information./ppSupport clinical trials through protocol development, investigator selection, training, medical monitoring, safety review, data analysis and interpretation, quality control and publication activities./ppProvide therapeutic expertise across lifecycle documentation, including risk management files, clinical evidence reports, summaries of safety and clinical performance, vigilance reporting, health risk assessments and product labeling./ppLead post-market safety signal detection, assessment and reporting, partnering with field personnel and health care professionals to evaluate adverse events and device performance./ppMonitor and assess adverse events to determine appropriate escalation and communication to senior leadership regarding emerging safety concerns./ppAuthor, review and approve clinical, scientific and safety reports supporting regulatory submissions, risk management and post-market surveillance activities./ppReview and approve educational and promotional materials and clinical trial protocols to ensure accuracy, alignment with standards of care and compliance with quality policies./ppContribute to evaluation, development and integration of new and acquired technologies, providing medical expertise for due diligence and strategic initiatives./ppRequired qualifications:/ppMD degree or accepted international equivalent/ppExperience as a neurologist or pain management specialist/ppBoard certified or board eligible in neurology, pain management or physical medicine and rehabilitation, or equivalent international certification/ppValid, unrestricted license to practice medicine in good standing/ppMinimum of 5 years clinical experience in neurology or pain management, or minimum of 7 years combined clinical and industry experience in a life sciences environment/ppExpertise in neurology and movement disorders, including deep brain stimulation, or in interventional pain management, including spinal cord stimulation and advanced procedures/ppLeadership experience in a matrixed or cross-functional environment/ppKnowledge of clinical statistical principles/ppAbility to communicate complex medical concepts to diverse audiences through presentations and written reports/ppKnowledge of regulations and standard practices governing clinical research/ppStrong written and verbal communication skills/ppPreferred qualifications:/ppStrong analytical skills and attention to detail/ppExperience within a medical device company in medical safety, medical affairs, clinical, research and development, quality or regulatory functions/ppExperience working in organizations with both legacy and acquired entities/ppExperience as a clinical investigator in a medical device research study/ppExperience applying risk management principles/ppKnowledge of global medical device regulations/p/div