Jobs at BeiGene

Lead global clinical operations for designated oncology programs, managing gCSM teams, strategic program planning, budgets, resource allocation, vendor governance, regulatory compliance (ICH/GCP), and cross-functional collaboration to ensure timely, high-quality execution of multi-region clinical trials.

Support and maintain a GMP small-molecule manufacturing facility including commissioning, qualification, validation, preventive maintenance, and equipment troubleshooting (blenders, granulators, mills). Serve as SME, lead fault analysis and remediation, manage facility assets, collaborate with global engineering and cross-functional teams, and provide people leadership and project management support.

The role involves supporting the Regional Clinical Study Manager in executing clinical studies, ensuring quality standards, and coordinating with various stakeholders. Responsibilities include managing study logistics, maintaining documentation, and assisting with regulatory submissions.

Lead clinical study start-up activities, including investigator and site identification, feasibility assessments, IRB and regulatory submissions, essential document preparation, informed consent finalization, site contract and budget negotiation, subject compensation and insurance review, and recruitment material localization. Ensure timelines, cost, quality, and ICH/GCP compliance while mentoring start-up specialists and collaborating across functions.

Manages regional GCP compliance and inspection readiness across clinical studies, countries, and investigator sites. Conducts risk evaluations and site compliance visits, identifies and escalates noncompliance, assesses observations, oversees CAPA resolution, maintains compliance documentation and dashboards, and supports inspections. Provides guidance to clinical study teams, analyzes trends, mentors colleagues, and contributes to SOPs and process improvements. Requires substantial clinical operations, trial oversight, and GCP compliance experience, with frequent travel.

Executes commercial pharmaceutical quality assurance activities for externally manufactured APIs, drug products, and finished goods. Responsibilities include batch record review, data verification, batch disposition, quality system records, deviations, CAPAs, regulatory request support, inspection readiness, metrics tracking, and SOP maintenance. The role collaborates with CMOs and cross-functional stakeholders to support compliant, timely product release and commercial supply continuity within GMP-regulated environments.

Develops, expresses, purifies, and characterizes recombinant proteins using bacterial and mammalian systems for antibodies, enzymes, structural biology, and drug discovery applications. Maintains protein inventories, plasmids, reference lots, QC data, and high-quality ELN records. Improves protein production workflows for quality, scalability, and turnaround time; collaborates across disciplines, supports research initiatives, communicates progress, and may coordinate CRO partners or provide project leadership.

Leads the site-wide GMP training program, ensuring compliance, effectiveness, and inspection readiness. Serves as the training subject matter expert and business process lead for global GxP training initiatives, eLMS projects, governance, and harmonization. Responsibilities include developing curricula and training matrices, managing training compliance and metrics, supporting audits and inspections, investigating deviations and CAPAs, implementing Train-the-Trainer programs, and improving training effectiveness across departments.

Supports biopharmaceutical facility startup through design reviews, equipment procurement and testing, protocol execution, training, and automation debugging. Performs hands-on cGMP manufacturing, including cell culture, media and buffer preparation, chromatography, filtration, formulation, aseptic vial filling, inspection, packaging, equipment operation, cleanroom activities, batch documentation, deviations, change controls, and CAPA support. Assists supervisors with daily workload management and collaborates across teams in a physically demanding, shift-based environment.

Leads corporate account management and market access strategies for oncology products across Northeast IDNs, health systems, GPOs, and cancer centers. Builds C-suite and healthcare stakeholder relationships, drives contract pull-through and patient access, supports reimbursement, and coordinates cross-functional teams across medical, legal, compliance, pricing, contracting, trade, and sales. Conducts account business reviews and removes access barriers. Requires significant pharmaceutical, oncology, account management, contracting, negotiation, and marketplace launch experience.

Lead country-level GCP compliance for clinical trials using a risk-based approach. Provide regulatory and procedural guidance, perform site oversight and compliance visits, manage CAPAs, support audits/inspections, and collaborate with regional and global stakeholders to protect patient safety and data integrity.

Leads Japan clinical investigator payment operations across study startup, maintenance, and closeout. Oversees payment vendors, workflows, approvals, KPIs, compliance, issue resolution, and audit-ready documentation. Partners with clinical operations, contracts, budgets, finance, accounts payable, and technology teams to ensure accurate and timely payments. Analyzes payment data, manages Japan-specific tax and invoicing requirements, improves processes, and supports reporting, training, and technology enhancements.

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.

Completes a 12–14-week CRA training program before managing clinical trial sites. Conducts site visits, monitors protocol and regulatory compliance, evaluates data quality and patient safety, provides site training, tracks enrollment and data metrics, reconciles serious adverse events, communicates site performance, supports audits and inspections, and helps deliver study milestones. The role requires up to 70% travel and collaboration with clinical study teams and site personnel.

Manage and develop relationships with key accounts (wholesalers, payers, oncology institutions), execute segmentation and negotiation strategies, promote oncology/hematology products, support product launches, maintain CRM records, analyze market needs and sales data, collaborate with medical and sales teams, and travel frequently (30–50%). Requires strong digital/CRM skills and deep knowledge of the Colombian healthcare system.

Leads pharmaceutical sales strategy and execution across the Northeast/Tri-State territory, managing Account Managers focused on hematology and solid tumor accounts. Responsibilities include hiring, resource planning, performance management, strategic account initiatives, KPI analysis, cross-functional collaboration, training, customer relationship development, and exceeding sales goals. The role requires extensive specialty pharmaceutical sales and management experience, oncology market expertise, and 50% travel.

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.

Manage country- and site-level GCP compliance for clinical trials using a risk-based approach. Provide regulatory guidance, conduct site compliance visits, support audits/inspections, manage CAPAs, and communicate trends to Clinical Operations and global stakeholders to ensure patient safety, data integrity, and inspection readiness.

Lead global CMO site management for clinical labeling and packaging (APAC focus). Oversee product flow from drug product release through final packaged goods, manage schedules, vendor performance, RFQs/SOWs, QA agreements, metrics reporting, and cross-functional stakeholder communication to ensure supply continuity, cost control, quality, and continuous improvement.

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.