Senior Manager Medical Operations
Core
Lead medical affairs activities across the in vitro diagnostics (IVD) product lifecycle, providing scientific and clinical expertise to support product development, regulatory compliance, risk management, and post-market activities.
Role type
Senior Manager, Medical Operations (Medical Affairs)
Builds
IVD diagnostic products and clinical evidence packages
Domain
Healthcare / In Vitro Diagnostics (IVD)
Required skills
PhD in Life Sciences/Immunology/Clinical Research or MD, 7+ years experience, clinical safety and risk assessments, benefit-risk evaluations, cross-functional team leadership, training program development, process improvement
Preferred skills
IVD/diagnostics expertise, post-market surveillance knowledge, translating clinical data to business recommendations
Technologies
None stated
Responsibilities
Provide expert medical and clinical assessments of IVD products, serve as subject matter expert for Medical Operations, lead clinical safety and risk assessments, represent Medical Operations in cross-functional teams, support investigations and CAPAs, manage and prioritize Medical Operations activities, develop training programs, drive continuous improvement initiatives
Seniority
Senior Manager, hands-on leadership
