Jobs at BeiGene

Leads global clinical biomarker and translational medicine strategies for solid tumor oncology programs. Oversees biomarker assay development, validation, data analysis, companion diagnostic initiatives, regulatory contributions, and clinical trial advancement. Partners with cross-functional teams, CROs, academic institutions, and industry collaborators while translating biomarker findings into development recommendations. Requires scientific leadership, oncology biomarker expertise, publication or regulatory experience, mentoring capability, and Mandarin proficiency.

Supports hematology clinical studies through protocol and statistical analysis plan development, database review, clinical trial data analysis, regulatory submissions, and clinical study reports. Collaborates with clinical, regulatory, programming, and data management teams; interprets results; responds to study-related queries; contributes to manuscripts and presentations; and supports innovative statistical methods in clinical development.

Leads R&D data stewardship across metadata, cataloging, data products, profiling, quality, governance, and compliance. Uses Informatica, SQL, Databricks, Python, and PySpark to curate data, automate workflows, define quality controls, and resolve complex issues. Applies AI-assisted stewardship and semantic data concepts while collaborating with technical and business stakeholders. Coaches other stewards, supports audit readiness, and improves stewardship standards and operating practices.

Leads digital clinical operations capabilities across the clinical trial lifecycle, focusing on CTMS enhancements, process optimization, requirements gathering, prioritization, roadmaps, user acceptance testing, and technology value realization. Partners with Clinical Operations, IT, Development, QA, and vendors to deliver compliant, efficient, and innovative solutions. Manages stakeholder communications, champions, backlogs, business outcomes, change adoption, and project progress while supporting validated systems and clinical operations technology.

Leads global commercial strategy, launch readiness, brand planning, and lifecycle management for an oncology asset. Builds and directs a cross-functional Global Brand Team, aligns R&D, commercial, regional, and affiliate stakeholders, develops competitive and growth strategies, translates clinical evidence into market narratives, and supports global commercialization, supply planning, and stakeholder communications.

Leads executive and specialized scientific talent sourcing for Research organizations. Builds global talent pipelines, maps competitive talent landscapes, develops scientific networks, engages passive candidates, and provides talent intelligence to leaders and hiring managers. Maintains strategic talent communities, tracks scientific talent movements, leverages sourcing technologies, and advises on workforce planning and talent attraction strategies.

Leads U.S. Commercial and Market Access compliance for a pharmaceutical organization. Advises senior leaders on healthcare compliance, payer and customer engagement, pricing, contracting, patient access, promotions, and commercial initiatives. Oversees risk assessments, monitoring, audits, investigations, remediation, policies, training, governance, and launch readiness. Builds cross-functional partnerships, translates regulations into practical guidance, and manages Compliance team members.

Leads data management activities across multiple hematology clinical studies and programs. Oversees data managers, timelines, data quality, EDC database development, validation, vendor deliverables, documentation, standards, training, compliance, and inspection readiness. Partners with clinical study teams, CROs, laboratories, and cross-functional stakeholders to resolve issues, improve processes, and ensure consistent, high-quality clinical data management.

Leads data management activities across multiple hematology clinical studies and programs, overseeing data managers, vendors, timelines, database development, data quality, compliance, and inspection readiness. Develops standards, SOPs, training, and process improvements while partnering with cross-functional study teams, CROs, laboratories, and clinical development stakeholders. Serves as a primary data management contact and troubleshoots operational issues.

Provides biostatistical support for real-world data and real-world evidence studies. Develops protocols and statistical analysis plans, selects methodologies, analyzes large healthcare datasets, interprets findings, and communicates results. Collaborates on database design, statistical programming, vendor document review, research into innovative methods, training, and statistical consultation across clinical development and commercial functions.

Leads end-to-end global clinical study operations from start-up through closeout, managing timelines, enrollment, quality, budgets, risks, vendors, regional teams, regulatory deliverables, data collection, inspections, and cross-functional stakeholder alignment. Oversees study feasibility, site selection, monitoring, trial master file quality, clinical supplies, audit readiness, and resource allocation while mentoring team members and improving operating procedures.

Leads global commercial strategy and operations for Tacabrutideg, driving hematology product growth, lifecycle planning, launch readiness, brand performance, market adoption, and value maximization. Aligns global, regional, cross-functional, and senior leadership stakeholders; oversees brand team and planning processes; supports investor communications; and partners with technical operations on supply and demand. Requires extensive pharmaceutical marketing experience, global product launches, hematology or oncology expertise, and international collaboration.

Leads global regulatory compliance, risk management, audit and health authority inspection readiness programs. Oversees Veeva RIM data stewardship, regulatory information quality, compliance KPIs, dashboards, remediation, root-cause analysis, and continuous improvement across Regulatory Affairs and cross-functional GxP teams. Provides senior leadership reporting, coaches stakeholders, and drives corrective actions through implementation and effectiveness monitoring.

Leads global clinical operations for designated programs, overseeing gCSM teams, program strategy, budgets, resource allocation, feasibility, vendor governance, and regulatory compliance (ICH/GCP). Drives operational excellence, cross-functional collaboration, talent development, process improvement, and represents Clinical Operations in governance and KOL engagement across international time zones.

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 global comparator sourcing strategy for clinical supply, ensuring timely access to comparator medicines. Build supplier partnerships, market intelligence, and supply resilience; sponsor digital/process transformation; manage cross-functional alignment and regulatory compliance (cGMP/GCP/21 CFR etc.); lead and develop a global team while driving performance improvements, risk mitigation, and business impact reporting.

Support the Global Clinical Study Manager in global clinical trial delivery by managing study systems (eTMF, CTMS, SharePoint), tracking key study deliverables, coordinating cross‑functional meetings, assisting with TMF QC, study planning, vendor and budget support, and contributing to data cleaning, study communications, and study drug supply activities to ensure quality, timelines, and compliance with ICH‑GCP.

Manage biomarker operational work for clinical trials, oversee junior project managers, and collaborate with internal and external stakeholders to ensure project success.

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.