Jobs at BeiGene

Lead UK & Ireland regulatory strategy and submissions for oncology development and commercial products. Manage UK MAA dossiers, MHRA interactions, labeling and compliance, mentor junior staff, advise UK leadership, and represent the company at industry meetings. Ensure regulatory risk mitigation and cross-functional alignment throughout product lifecycle.

Lead development and implementation of analytics and predictive models to support R&D Quality oversight across clinical, safety, laboratory, and vendor data. Build dashboards, risk indicators, automated monitoring, and audit-support tools; integrate complex data to identify portfolio-level risks and translate findings into actionable quality recommendations that support GCP/GVP/GLP/GCLP compliance and inspection readiness.

Execute clinical monitoring activities for oncology/hematology trials per ICH-GCP and SOPs. Manage site selection, initiation, routine monitoring, data quality, regulatory submissions, inspection readiness, and site performance. Collaborate with Clinical Operations to meet study milestones and propose CAPAs to address issues.

Provide strategic statistical leadership for EU HTA and JCA submissions, collaborate cross-functionally and with vendors, design and review analyses and models (economic modeling, indirect comparisons, observational studies), supervise statistical programming outputs, train staff, ensure standards and readiness for EU HTA, and review vendor-supplied data and analyses.