Medical Safety Lead

Job Summary

Leading integrated medical safety and pharmacovigilance strategy, the full-time Medical Safety Lead will oversee clinical safety surveillance, translate preclinical data into clinical safety strategies, and manage external pharmacovigilance providers for a biotech company focused on novel therapeutics.

Key responsibilities

• Lead the development and implementation of medical safety strategies across a portfolio of biologics and oral therapeutics
• Provide medical oversight for clinical safety surveillance, adverse event assessment, and benefit-risk evaluations
• Establish safety infrastructure and processes to support the organization's clinical portfolio expansion

Required qualifications

• MD with clinical training in immunology, inflammation, or a related medical specialty
• 5-7 years of experience in biotechnology or pharmaceutical medical safety with leadership responsibilities
• Experience in leading safety strategy through early clinical development, including first-in-human studies
• Strong understanding of global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines
• Background in biologics and immune-modulating therapeutics, with relevant experience in antibodies/bispecifics