Medical Director, MDMS NEW

Job Summary:

The medical director, medical safety (MDMS) 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 technological 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.

This 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.

Job Responsibilities:

• Serve 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.
• Provide 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.
• Collaborate with internal partners including clinical, clinical evidence, quality, research and development, regulatory, post-market surveillance, marketing and business development to ensure comprehensive safety oversight.
• Engage on behalf of the company with investigators, regulatory bodies, key opinion leaders, physician customers, professional societies and advisory boards on matters of device performance and medical safety.
• Interact with independent committees, including clinical event committees and data monitoring committees, ensuring transparent and effective exchange of safety information.
• Support clinical trials through protocol development, investigator selection, training, medical monitoring, safety review, data analysis and interpretation, quality control and publication activities.
• Provide 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.
• Lead post-market safety signal detection, assessment and reporting, partnering with field personnel and health care professionals to evaluate adverse events and device performance.
• Monitor and assess adverse events to determine appropriate escalation and communication to senior leadership regarding emerging safety concerns.
• Author, review and approve clinical, scientific and safety reports supporting regulatory submissions, risk management and post-market surveillance activities.
• Review and approve educational and promotional materials and clinical trial protocols to ensure accuracy, alignment with standards of care and compliance with quality policies.
• Contribute to evaluation, development and integration of new and acquired technologies, providing medical expertise for due diligence and strategic initiatives.

Qualifications:

Required:

• MD degree or accepted international equivalent
• Experience as a neurologist or pain management specialist
• Board certified or board eligible in neurology, pain management or physical medicine and rehabilitation, or equivalent international certification
• Valid, unrestricted license to practice medicine in good standing
• Minimum of 5 years’ clinical experience in neurology or pain management, or minimum of 7 years of combined clinical and industry experience in a life sciences environment
• Expertise in neurology and movement disorders, including deep brain stimulation, or in interventional pain management, including spinal cord stimulation and advanced procedures
• Leadership experience in a matrixed or cross-functional environment
• Knowledge of clinical statistical principles
• Ability to communicate complex medical concepts to diverse audiences through presentations and written reports
• Knowledge of regulations and standard practices governing clinical research
• Strong written and verbal communication skills

Preferred:

• Strong analytical skills and attention to detail
• Experience within a medical device company in medical safety, medical affairs, clinical, research and development, quality or regulatory functions
• Experience working in organizations with both legacy and acquired entities
• Experience as a clinical investigator in a medical device research study
• Experience applying risk management principles
• Knowledge of global medical device regulations