Jobs at BeiGene

Lead delivery of study start-up activities across the Americas, ensuring timely submissions, central IRB setup, site feasibility and activation, resource forecasting, process improvements, and compliance with ICH/GCP and SOPs. Manage and mentor SSU teams (line and FSP), drive KPIs, and support workflow optimization and stakeholder communication.

Lead global clinical site contracting strategy and operations, overseeing contract lifecycle (CTAs, MSAs, investigator agreements, etc.), negotiation, compliance, and study startup risk mitigation. Manage and develop a global contracts team, drive process improvements, KPIs, vendor governance, cross-functional collaboration with Legal/Finance/Clinical/CROs, and ensure inspection readiness and financial alignment to accelerate study startup and portfolio delivery.

Lead global clinical program operations for designated oncology programs, managing gCSM teams, budgets, resource allocation, vendor governance, and program KPIs. Provide strategic clinical operations input to cross-functional teams, ensure ICH/GCP-compliant trial execution, mentor staff, drive process improvements, and support onboarding and execution of external partnership studies across time zones.

Lead global clinical study delivery from feasibility through closeout for partnership studies, managing cross-functional teams, vendors, budgets, timelines, quality, RBQM, TMF, inspection readiness, and regulatory compliance to ensure on-time, high-quality execution.

Lead global clinical process management within GCO by developing, revising, and implementing SOPs, work instructions, and standards. Serve as liaison to regional heads and SMEs, drive process adoption, change management, training, and continuous improvement. Oversee document approval workflows, assess regulatory and operational impacts, escalate key issues, and mentor Associate Directors to ensure consistent global process leadership and compliance with ICH-GCP.

Lead and manage statistical programming for multiple clinical studies: produce and validate SAS-based SDTM/ADaM datasets, tables, listings, graphs, and macros for regulatory submissions; coordinate cross-functional partners, support resourcing, vendor interactions, and contribute to SOPs and programming standards.

Lead statistical programming for multiple clinical development projects, ensuring quality and compliance while collaborating with cross-functional teams and overseeing data analysis.

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.

Lead and manage regional clinical study management team, ensuring on-time, quality trial delivery. Oversee resourcing, capability development, SOP and risk adherence, stakeholder collaboration, budgeting, hiring, performance management, and continuous improvement across the region.

Lead the strategy and implementation of AI solutions in R&D, driving adoption and improving operational efficiency through advanced analytics. Collaborate with cross-functional teams to design AI/ML models and evaluate new technologies.

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.

Lead lifecycle management and global portfolio strategy for partnership drug development programs. Oversee project plans, budgets, KPIs, risk management, alliance management, process improvements, governance, and cross‑functional coordination to ensure high‑quality execution of external partner studies on the company’s Clinical SuperHighway.

Lead global Clinical Business Operations strategy, governance, and financial stewardship for investigator budgets, site contracts, payments, and budget data. Drive KPI monitoring, compliance (ICH-GCP), vendor oversight, automation/digital initiatives, workforce planning, and cross-functional alignment with Finance, Legal, and Clinical Operations.

Lead and execute a global, risk-based audit program for GxP computerized systems. Assess validation, change management, data integrity, cybersecurity, vendor oversight, and compliance with 21 CFR Part 11, EU Annexes, and industry guidance. Drive audit planning, reporting, CAPA evaluation, inspection readiness, governance, and continuous improvement while partnering across Quality, IT, Manufacturing, Clinical, Regulatory, and third parties.

Lead statistical analyses for Real-World Data (RWD) and Evidence (RWE) studies, oversee programming deliverables, analyze large datasets, and provide statistical consultation for biostatistics projects.

Lead development and execution of clinical trial supply plans, ensuring timely IMP delivery and GMP-compliant inventory management. Oversee label/pack, distribution, IRT strategy, vendor CMOs, investigations/CAPAs, budget management, process improvements, and mentor direct reports while representing Clinical Supply Chain on cross-functional study and program teams.

Lead and coordinate biostatistical activities for hematology clinical studies: develop protocols and SAPs, ensure data quality, analyze trial data, prepare CSR content and regulatory responses, collaborate with programming, data management, and cross-functional teams, and contribute to methodological research and scientific communications.

Lead development and execution of market access strategy for hematology portfolio. Translate clinical, economic, and RWE into payer/provider messaging, develop payer-facing tools, support launch readiness and lifecycle management, partner cross-functionally (HEOR, Medical Affairs, Pricing, Sales), gather customer insights, define success metrics, and drive alignment to ensure access and reimbursement objectives are met.

Lead stewardship of Pharma R&D master data domains, manage a team of data stewards, operationalize governance and metadata standards, monitor and remediate data quality, collaborate with cross-functional stakeholders, and drive adoption of stewardship practices and metrics to enable trusted data for AI/ML and analytics.

Lead end-to-end companion diagnostic (CDx) strategy and execution aligned with clinical programs. Partner cross-functionally and with external IVD collaborators, define target product profiles, support regulatory submissions (e.g., IDE/PMA), oversee assay and kit development (NGS, IHC, FISH), manage timelines/budgets, and communicate risks and progress to stakeholders to enable diagnostic approval and commercial launch.