Teams at Biogen

Leads international regulatory strategy and submissions for high-risk Class III implantable and combination medical devices across Japan, China, and Latin America. Manages regulator interactions, country-specific plans, deficiency responses, lifecycle maintenance, post-market surveillance, and marketing compliance. Partners with Quality, Clinical, Medical Safety, and global regulatory teams while mentoring staff and supporting inspection readiness.

Leads end-to-end clinical trial operations, including study strategy, protocol development, CRO oversight, risk mitigation, quality, timelines, budgets, and compliant execution. Chairs study management teams and coordinates cross-functional drug development activities across neurological and nephrology programs. Requires strong clinical operations leadership, GCP and ICH expertise, CRO management, project management, and scientific knowledge.

Supports early-phase immunology and neuroimmunology clinical development programs, including protocol design, trial execution, medical monitoring, data interpretation, regulatory interactions, safety planning, and clinical documentation. Partners with cross-functional R&D teams, CROs, investigators, and external stakeholders while providing therapeutic expertise and monitoring developments in autoimmune disease.