Global Medical Development Manager
Core
Provides medical development expertise and supervision for biosimilar and generic medicines during the development phase, integrating medical, clinical, scientific, and regulatory perspectives to support pipeline selection and strategy.
Role type
Senior IC medical development manager (generics/biosimilars)
Builds
Clinical development plans, study protocols, safety reports, and registration dossiers for new pharmaceutical products
Domain
Pharmaceuticals (Generics and Biosimilars)
Required skills
Clinical study design, pharmacology, pharmacokinetics, pharmacodynamics, benefit-risk assessment, regulatory interactions, safety signal detection, literature review, medical writing
Preferred skills
Experience with lean clinical strategies, contract research organization management, publication of study results
Technologies
DSURs, investigator brochures, clinical development plans, risk management plans
Responsibilities
Provide medical input for product selection and development strategy; contribute to clinical study design and safety documentation; monitor and interpret clinical safety information; prepare medical launch materials and product packs; engage with Health Authorities and external experts.
Seniority
Senior, hands-on IC
