Jobs at BeiGene

Lead global strategic feasibility for clinical studies by integrating internal and external data, advising country/site selection, recruitment and operational strategies, improving feasibility processes and tools, and partnering with program and study teams to optimize study design and execution across early to late-stage programs.

The Associate Director will drive digital tool adoption, develop communication strategies, train users, monitor progress, and oversee AI capabilities in Quality processes.

Lead the U.S. Biologics Regulatory CMC organization, develop global CMC regulatory strategies, oversee CMC submissions and health authority interactions, manage a ~15-person team, ensure compliance and inspection readiness, and support lifecycle management for biologics including mAbs, ADCs, cell therapies, and combination products.

Lead external supply quality for commercially manufactured small and large molecule products in the US. Oversee CMO oversight, change control, deviations, CAPA, inspections, batch release, quality agreements, lifecycle management, PIPs, and cross-functional collaboration. Manage and develop a US-based team and ensure compliance with regulatory and BeOne quality standards.

Lead and mentor oncology program management teams, develop global product strategies, manage projects, and drive process improvements in drug development.

The Executive Director will lead global commercial strategies for TEVIMBRA, oversee cross-functional teams, and ensure alignment with business objectives to drive brand growth in oncology/hematology.

Oversee GxP and Quality incident management, ensure regulatory compliance, lead cross-functional collaboration, and develop training on incident management procedures.

The Director, Clinical Development oversees clinical programs in oncology, ensuring successful strategy execution, managing studies, and collaborating across functions and organizations to improve cancer treatment.

The role involves leading global forecasting and performance management, setting standards, overseeing processes, collaborating with cross-functional teams, and developing a high-performing team in the oncology biotech sector.

The intern will assist in regulatory projects related to CMC, support document preparation, maintain regulatory information, and contribute to process improvements while gaining hands-on biotech experience.

Lead strategic planning, process improvement, and operations for the CMO Solid Tumors office. Manage cross-functional initiatives, resource and budget planning, vendor tracking, and dashboards; facilitate meetings and issue resolution; standardize processes and metrics to improve efficiency, quality, and performance across clinical development functions.

Manage clinical drug supply planning, label/pack and distribution for clinical studies. Develop and oversee supply and inventory plans, manage GMP inventory and vendor relationships, support IRT strategy and UAT, investigate exceptions and implement CAPAs, and lead cross-functional process improvements to ensure continuous patient supply and minimize waste.

Lead global distribution and trade operations for finished goods, APIs and drug products. Ensure cGMP/GSP/GDP compliance, manage carriers/3PLs, import/export/customs, temperature-controlled logistics, vendor performance, SOPs, ERP transactions (SOX-compliant), risk assessments, audits, and cross-functional coordination to support production schedules and continuous improvement.

The Associate Director, Regulatory Affairs will manage regulatory projects, provide strategic guidance, and ensure compliance with regulatory requirements while developing market access strategies for products.

The Senior Manager, Global Market Research will lead market research initiatives for BeOne's oncology products, support commercialization strategies, and deliver actionable insights to cross-functional teams.

The Senior Associate assists in the review and compliance of promotional materials for regulatory submissions, ensuring adherence to guidelines and collaboration with cross-functional teams.

Lead and develop clinical trial supply strategy within Global Supply Chain, ensuring timely drug supply and risk management while mentoring team members and collaborating cross-functionally.

The Regional Clinical Study Senior Manager is responsible for overseeing regional study delivery, managing clinical operations teams, ensuring compliance with quality standards, and collaborating with stakeholders on study progress and strategy.

The Associate Director, Compliance will manage compliance initiatives across North America, ensuring adherence to regulatory standards, providing guidance, training, and leading risk management efforts while promoting a culture of integrity.

Lead regional clinical operations for an assigned portfolio, ensuring timely, budgeted delivery and inspection readiness. Manage and mentor regional clinical study managers, align resources and vendors, drive feasibility, site selection, execution, data quality, SOP/work instruction development, and cross-functional collaboration. Oversee budgeting, forecasting, and stakeholder communications across region and support global study planning and clinical report activities.