Global Medical Development Manager
Core
Provides medical development expertise and supervision for assigned biosimilar and generic medicine products during the development phase, integrating medical, clinical, scientific, regulatory, and patient safety perspectives to support pipeline selection and development strategy.
Role type
Senior IC medical development manager (pharmaceuticals)
Builds
Scientifically justified, patient-focused development approaches and regulatory submission dossiers for biosimilar and generic medicines
Domain
Pharmaceuticals (Biosimilars and Generics)
Required skills
Clinical study design and methodology, clinical data interpretation, benefit-risk assessment, regulatory interaction management, medical literature review, patient safety risk mitigation, pharmacology and pharmacokinetics knowledge, treatment guideline analysis, cross-functional collaboration, external expert engagement
Preferred skills
Experience in generics drug development, global or multi-country development activities, background in pharmacovigilance, experience with Health Authority responses
Technologies
Clinical development plans, investigator brochures, DSURs, risk management plans, clinical study reports, registration dossiers
Responsibilities
Provide medical input for product selection and development strategy; generate medical insights from internal and external data sources; collaborate with cross-functional teams on compliant development deliverables; engage with Health Authorities and external service providers; monitor and interpret clinical safety information; prepare development-phase safety deliverables and registration dossiers; supervise publication-related activities
Seniority
Senior, hands-on IC