Jobs at BeiGene

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.

Lead global strategic feasibility for clinical studies by integrating regional data, tools, and stakeholder input to inform country/site selection, recruitment and retention strategies, predictive modelling, risk/mitigation plans, and operational recommendations supporting study design and execution across development stages.

The Senior Clinical Research Associate manages clinical study sites, ensuring compliance with protocols, mentoring CRAs, and optimizing study performance while adhering to regulatory standards.

Lead Program & Study Management (P&SM) operations to drive process optimization, operational excellence, and strategic initiatives for global clinical study execution. Identify improvement opportunities, implement change, align cross-functional teams, ensure ICH/GCP and regulatory compliance, and develop training to enhance clinical project management capabilities. Influence long-term strategy and support global study teams while managing resources, budgets, and performance tracking.

The role involves leading a regional clinical study management team, ensuring trial delivery, maintaining quality standards, managing budgets, and mentoring staff in a biotech environment.

Source and build pipelines of passive R&D candidates for clinical development, regulatory, safety, biostats and data science. Partner with recruiters, hiring managers and HRBPs to develop sourcing strategies, provide market intelligence, curate candidate slates, report progress, and optimize sourcing approaches using analytics and automation tools.

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.

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

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

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 and manage Global Study Management Associates across regions, overseeing resourcing, training compliance, study delivery, quality and inspection readiness, process improvement, stakeholder collaboration, and team development. Drive operational excellence, mentor staff, support hiring, and ensure alignment with regulatory standards and organizational strategy.

Leads global regulatory project management across the drug development lifecycle, translating regulatory strategies into submission plans for IND/CTA, NDA/BLA, and MAA applications. Coordinates cross-functional and cross-regional teams, manages risks and timelines, oversees documentation quality, supports market access, advises senior regulatory leaders, and drives process improvements. The role also mentors junior staff and may develop into a formal people-management position.

Oversee clinical monitoring activities and CRA team performance across clinical trials, ensuring compliance with ICH-GCP, regulations, and company SOPs. Allocate resources, review quality, support audits and inspections, manage risk resolution, approve expenses, and improve clinical operations. Lead recruitment, onboarding, performance evaluations, mentoring, task assignments, and career development. Collaborate cross-functionally, strengthen site relationships, and lead strategic task forces. Oncology experience and clinical research leadership are highly valued.

Leads program management for oncology drug development and product lifecycle management. Develops global product strategies, integrated project plans, budgets, milestones, risk practices, and governance processes. Facilitates cross-functional alignment, team decision-making, stakeholder communication, and delivery of development goals. Supports process improvement, team planning, project oversight, alliance management, and steering committees. Requires substantial clinical and drug development experience in the biotechnology or pharmaceutical industry.

Manages clinical trial drug supply activities, including demand planning, supply and inventory plans, production schedules, labeling, packaging, comparator sourcing, IRT strategy and testing, shipment coordination, and import licenses. Collaborates with clinical operations, regulatory, quality, CMC teams, CMOs, depots, vendors, and study stakeholders to ensure continuous patient supply, minimize waste, monitor schedules, and mitigate risks.