Jobs at BeiGene

Lead global regulatory strategy and operational oversight for partnered oncology development programs. Manage regulatory submissions (IND/CTA, NDA/MAA/BLAs), health authority interactions, lifecycle management, and cross‑functional alignment to ensure timely study execution and approvals. Provide mentorship, policy interpretation, KPI reporting, and strategic guidance across regions to support onboarding and delivery of external partner assets on the company's clinical development platform.

Senior, field-based leader managing and developing the Scientific Partnership Medical Director team while personally managing priority US health system accounts. Defines enterprise health system engagement strategy, aligns medical and commercial account plans, fosters KOL relationships, champions evidence-generation opportunities, ensures compliance, manages budget and KPIs, and represents the company at national oncology forums.

Lead and manage regional clinical operations for assigned study(ies), overseeing regional teams and vendors, ensuring study startup, execution, TMF maintenance, regulatory/IRB submissions, inspection readiness, timelines, budget management, and cross-functional stakeholder communication through closeout.

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.

Lead systems engineering for R&D platforms, integrating externally developed solutions with enterprise IT standards. Design and deploy HPC and containerized environments, observability, data lakes, and robust API/data bus architectures. Serve as SME for foundational AI architectures (RAG, vector storage, agentic and multi-modal pipelines). Drive cloud migrations, governance, compliance (GxP/21 CFR Part 11), vendor assessments, and team development while aligning R&D systems with enterprise security and identity requirements.

Lead lifecycle management of global drug development programs by creating and maintaining schedules, managing risks, dependencies, budgets, and communications, facilitating team decisions, driving process improvements, and supporting cross-functional delivery to meet program milestones.

Lead the Global Development Technology Solutions function to define multi-year digital and technology roadmaps, translate scientific needs into technical requirements, oversee vendor-sourced systems lifecycle, drive AI/ML/genAI-enabled transformation, enforce data governance and compliance (CSV, 21 CFR Part 11), manage change adoption, and build a high-performing team to deliver Development-function digital capabilities across Clinical Operations, Safety, Regulatory, and Clinical Development.

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.