BeOne Medicines

Clinical Research

• Accountable for regional study delivery with inspection readiness quality, within agreed timelines and budget
• Act as regional lead for multiple studies across an indication or program
• Lead regional clinical operations teams and external regional partners
• Serve as escalation point for regional study issues
• Align regional deliverables with overall study goals
• Develop regional tools, work instructions and SOPs
• Lead regional planning and management of clinical studies from feasibility through closeout
• Manage study start-up and recruitment timelines and track progress
• Drive trial feasibility, country allocation and site selection
• Coordinate local adaptations of global study documents and regulatory/ethics submissions
• Maintain regional and country information in study systems
• Collaborate with CRAs to ensure study execution and review monitoring reports
• Ensure regional and country-level Trial Master File creation, maintenance and quality control
• Provide input on clinical supplies, drug inventories, labels and comparator drug status
• Manage regional data collection, data entry and query resolution
• Support Clinical Study Report planning and execution
• Monitor compliance with protocol, SOPs, ICH/GCP and applicable regulations
• Ensure inspection readiness and prepare sites for audits and inspections
• Lead quality improvements and share best practices
• Select and manage regional vendors
• Manage regional study budgets
• Address investigator fees, site payments and patient travel reimbursement
• Manage regional resource needs and utilization
• Provide performance feedback and mentor junior team members

Regional Clinical Study Manager

Director

• Accountable for regional study or portfolio delivery with inspection-readiness quality, within agreed timelines and budget
• Act as regional lead for one or multiple studies across an indication or program
• Lead the regional clinical operations team, including external regional partners
• Serve as point of escalation for regional study or portfolio issues
• Develop regional tools, work instructions, and SOPs
• Drive regional trial and portfolio deliverables
• Lead planning and management of assigned clinical studies from feasibility through closeout
• Generate and maintain regional study start-up and recruitment timelines
• Drive regional trial feasibility, country allocation, and site selection
• Provide regional input on global study plans
• Coordinate local adaptations of global study documents and regulatory/EC/IRB submissions
• Ensure regional and country information in study systems and tools is current
• Coach and mentor CRAs; review and sign off monitoring reports as needed
• Ensure country and site-level Trial Master File creation, maintenance, and quality control
• Provide input on regional drug inventories, local drug labels, comparator drug regulatory approval, and reimbursement status
• Manage regional data collection, data entry, and query resolution
• Support Clinical Study Report planning and execution
• Monitor compliance with protocols, SOPs, ICH/GCP, and applicable regulations
• Maintain inspection readiness and prepare sites for audits and inspections
• Identify regional risks, implement solutions, and share best practices
• Lead improvements to study efficiency and quality
• Select and manage regional study vendors
• Manage and negotiate regional study budgets
• Coordinate investigator fees, site payments, and patient travel reimbursement
• Monitor regional resource utilization
• Ensure clinical team competencies meet company requirements
• Mentor junior team members and support development plans

Associate Director, Regional Clinical Study Management

• Accountable for regional study delivery with inspection-ready quality, agreed timelines and budget
• Lead the regional clinical operations team and oversee external regional partners
• Act as escalation point for regional study issues
• Align regional deliverables with overall study goals
• Lead regional operations meetings and represent the regional study team at internal and cross-functional meetings
• Plan and manage assigned clinical studies from feasibility through regional closeout
• Generate, manage and maintain regional study start-up and recruitment timelines
• Drive trial feasibility, country allocation and site selection with relevant stakeholders
• Provide regional input on global study plans
• Coordinate local adaptations of global study documents and support timely regulatory and EC/IRB submissions
• Ensure study submissions in assigned countries in collaboration with study start-up and regulatory teams
• Maintain regional and country information in study systems and tools
• Collaborate with CRAs on site execution and review/sign off monitoring reports
• Ensure country and site-level Trial Master Files are created, maintained and quality-checked
• Provide input on regional drug inventories, local drug labels, comparator drug approvals and reimbursement status
• Manage regional trial data collection, data entry and query resolution
• Support Clinical Study Report planning and execution
• Handle escalated site issues and monitor compliance with protocols, SOPs, ICH/GCP and regulations
• Ensure regional inspection readiness and implement solutions to study issues
• Prepare sites for audits and inspections and drive responses to findings
• Share learnings and best practices across teams
• Lead improvements and contribute to work instructions and SOPs
• Select and manage regional study vendors with sourcing
• Manage regional study budgets
• Coordinate investigator fees, site payments and patient travel reimbursement
• Identify regional resource needs and contingency plans
• Monitor regional resource utilization
• Provide performance feedback and mentor junior team members as needed

Compliance

• Develop and execute integrated U.S. regulatory strategies for assigned products and programs across clinical development, registration, post-approval commitments, and lifecycle management
• Provide authoritative U.S. regulatory advice to global regulatory leaders, development teams, governance committees, and senior management
• Assess strategic options, risks, trade-offs, and mitigation plans and integrate U.S. regulatory considerations into global strategies
• Serve as the primary regulatory leader for FDA engagement, planning, leading, and negotiating formal and informal interactions
• Oversee strategy, preparation, quality, and timely submission of INDs, NDAs, BLAs, supplements, amendments, meeting packages, briefing documents, responses to information requests, and other U.S. regulatory filings
• Incorporate U.S. regulatory requirements and FDA expectations into clinical development plans, evidence-generation strategies, labeling plans, and commercialization and lifecycle decisions
• Lead regulatory risk assessment and critical issue management, escalating significant risks and driving cross-functional alignment on mitigation and execution
• Maintain expert knowledge of FDA regulations, guidance, policy developments, and precedents and evaluate portfolio implications
• Build partnerships with Clinical Development, Medical, Safety, Biostatistics, Clinical Operations, CMC, Quality, Legal, Commercial, and other functions
• Represent Regulatory Affairs on senior cross-functional teams and governance forums and communicate complex regulatory matters to stakeholders
• Anticipate high-impact portfolio or program regulatory risks and direct mitigation, escalation, and risk-acceptance decisions
• Shape regulatory practices, operating approaches, innovation, future-state organizational capability, procedures, and process improvements
• Recruit, develop, coach, and retain regulatory talent; establish priorities and performance expectations
• Provide direct and matrixed supervision, capability building, succession planning, performance management, and development of a high-performing U.S. regulatory organization
• Represent the company in external industry forums and regulatory policy discussions as needed

Senior Director, Regulatory Affairs

General Counsel

• Provide strategic and practical legal support for R&D activities across Europe and selected New Markets
• Serve as a trusted partner to regional and global R&D stakeholders
• Advise on legal and regulatory issues throughout the product-development lifecycle
• Advise on the design, start-up and conduct of clinical trials and human-subject research
• Partner with Regulatory, Clinical Development, Global Clinical Operations, Safety, Medical and other functions to identify legal risks and develop mitigation strategies
• Draft, review and negotiate clinical trial, central-vendor, clinical-supply, technology and services agreements
• Advise on regional implementation of global R&D policies, standards, templates and processes
• Monitor legal and regulatory developments across supported markets and communicate actionable guidance
• Coordinate with Compliance, Privacy, Intellectual Property and other legal functions
• Support inspections, audits, investigations, disputes and remediation activities involving R&D matters
• Develop and deliver training and practical guidance for R&D colleagues
• Contribute to global R&D Legal knowledge management, process improvement and cross-regional collaboration

Director, R&D Counsel, Europe – New Markets

• Plan and manage regulatory activities for assigned projects spanning clinical, non-clinical, and CMC technical areas
• Assist in developing and implementing strategies for earliest possible approvals or clearance of regulatory submissions
• Manage preparation, writing, assembly, review, and timely submission of regulatory dossiers for product investigation and registration in the US and abroad
• Ensure regulatory submissions remain compliant with regulatory requirements
• Support and manage preparation of meeting requests and briefing documents
• Manage preparation, review, and submission of INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, and other submission components
• Participate on cross-functional project teams and provide regulatory expertise
• Develop and maintain current regulatory knowledge and advise management on significant developments
• Ensure compliance with departmental requirements and maintain the regulatory archive
• Work with external regulatory consultants and CROs as required

Senior Manager, Regulatory Affairs

Clinical Specialist

• Provide coordination and operational support to Process Leads and senior GCPM leadership
• Support document review and approval workflows
• Coordinate document control activities, including QA alignment, DCC activities, and approval tracking
• Gather, prepare, tabulate, and organize inputs for Process Lead review and decision-making
• Develop, document, and maintain project plans, including status reviews and follow-up
• Maintain stakeholder lists, meeting planning materials, and project charter drafts
• Support organizational change management activities and prepare draft communications
• Compile data from Veeva Vault or equivalent systems for status reporting and process reviews
• Prepare and maintain QE CAPA tables and tracking materials
• Prepare and analyze GCPM intake-form data for management review, process improvement, and innovation evaluation

Senior Global Clinical Process Management Specialist

• Advance early patient engagement, patient insights, and patient evidence generation across priority therapeutic areas and pipeline programs
• Integrate patient perspectives into medical strategy, clinical development, evidence generation, patient-centered trial engagement, patient education, trial awareness, and drug development
• Support patient evidence generation plans covering patient preference, burden of disease, patient experience, unmet need, outcomes, and plain-language evidence initiatives
• Identify patient evidence gaps and prioritize evidence-generation activities with cross-functional teams
• Develop patient insight narratives, evidence summaries, and materials supporting regulatory, payer, health technology assessment, and launch-readiness objectives
• Monitor evolving external expectations related to patient experience data, patient-focused drug development, and health technology assessment requirements
• Plan and execute patient advisory boards, patient organization engagements, listening sessions, and other insight-generation activities
• Translate patient and caregiver insights into recommendations for internal stakeholders
• Support integration of patient perspectives into trial design, recruitment and retention strategies, patient-facing materials, and burden-reduction approaches
• Support strategic engagement with professional societies, medical associations, and external experts
• Plan and execute professional society initiatives, sponsorships, and collaborations
• Ensure external engagements comply with company policies, laws, regulations, and compliance standards
• Partner across Medical Affairs, Clinical Development, Legal/Compliance, Corporate Communications, and external organizations
• Manage timelines, workplans, budgets, vendors, agencies, and project trackers
• Prepare executive-ready updates, decision points, risk flags, and leadership recommendations
• Contribute to annual planning, budget development, portfolio prioritization, and operational excellence
• Lead cross-functional teams and manage agencies without direct reports

Associate Director, Early Patient Engagement, Professional Societies

Account Executive

• Develop and execute strong local territory plans with cross-functional support to drive sales of approved medicines
• Build customized engagement plans based on customer needs
• Establish superior working relationships with healthcare professionals in the assigned territory
• Promote BeOne’s oncology products through value-added interactions with targeted HCPs
• Achieve territory-specific business and sales goals
• Implement sales plans aligned with marketing strategy
• Partner with Market Access to collect information and build commercial strategies aligned with customer needs and patient access
• Update and maintain the internal CRM database, including periodic information evaluation and updates
• Organize and conduct scientific events for HCPs in accordance with product strategy, company policies, and local codes of conduct
• Direct MSLs to off-label matters or questions not answerable with approved materials
• Use data and analytics to prioritize engagements and interactions
• Adjust engagement style based on customer channel preferences, focus, and behaviors
• Capture customer engagements and co-design cross-functional customer plans in the online CRM system
• Ensure operations comply with BeOne standards of conduct and applicable laws and regulations
• Work synergistically with internal stakeholders and contribute to a collaborative culture

• Lead global initiatives related to HCP promotions, non-personal promotions, and launch readiness for the BTK CDAC brand
• Develop a world-class brand and launch plan supporting an anticipated first-in-class product launch
• Lead creation and rollout of launch assets
• Lead congress asset planning for tacabrutideg
• Partner with Global Insights & Analytics, Medical Affairs, Global Market Access, and country marketing leads to create a strategic launch plan
• Lead the global omnichannel strategy for tacabrutideg
• Serve as global lead for all non-personal promotions
• Coordinate key functions and geographies to ensure launch excellence
• Develop KOL strategy and insights-gathering plan
• Collaborate with Global Medical, GCSO partners, and regions on strategic engagement plans
• Collaborate with GCSO team members focused on launch strategy, operations, and communications
• Partner with regional marketing teams on global promotional and competitive-readiness strategies
• Lead agency partners and cross-functional teams without direct reports
• Report to the Executive Director, Global Commercial Lead, Tacabrutideg

Director, Global Commercial, Tacabrutideg

General

• Plan, coordinate, and oversee the start-up process of clinical studies, ensuring deadlines and quality standards are met
• Collaborate with the Regional Submission Lead to deliver start-up milestones on time
• Provide country-specific study start-up expertise and support start-up activities, budget, and contract negotiations
• Review, manage, and translate Informed Consent Forms, adapting study templates to country requirements
• Retrieve essential documents from study sites and perform essential document site file reconciliation
• Conduct independent quality reviews of submission packages and submit packages to EC and HA when required
• Review and translate site-specific recruitment materials and other applicable documents
• Oversee and execute study protocol amendments throughout the study lifecycle
• Ensure inspection readiness of start-up study and site documentation
• Evaluate site practices and escalate quality or GCP issues as appropriate
• Identify site issues, propose corrective and preventative actions, identify gaps, and promote innovation
• Manage and coordinate start-up activities for IVDR studies when required
• Notify HAs of study conclusion and other required milestones
• Act as escalation point for SSUs regarding site-related issues and concerns
• May serve as subject matter expert for clinical operations, country regulations, and SSU-related activities

Study Start-up Specialist

• Act as line manager for trial monitoring staff (CRAs) in Belgium
• Plan, assign, and direct work; assess performance and guide professional development of direct reports
• Participate in hiring selection and allocate resources to clinical research projects
• Assign staff to clinical studies based on experience and training
• Ensure clinical trial protocols are executed according to ICH/GCP, local regulations, and applicable SOPs
• Collaborate with the Regional Clinical Operations Manager to maintain study timelines and quality standards
• Support study start-up and provide local expertise
• Manage study start-up and trial monitoring staff in accordance with company policies and regulations
• Ensure onboarding and training of new employees and oversee training plans
• Manage quality of assigned staff's clinical work through regular review and evaluation
• Provide country-specific study start-up expertise and review study documents, drug labels, ICFs, and templates
• Develop and review site-specific recruitment materials and tools
• Collaborate with study teams and clinical sites on IRB/EC submissions, TMF completeness, site activation, enrollment, and inspection readiness
• Contribute to feasibility, site identification, selection, and evaluation
• Perform accompanied CRA visits and assess performance
• Review visit reports, follow up on issue resolution, and communicate significant risks and proposed actions
• Monitor workload and quality metrics through regular review and reporting
• Anticipate and identify site issues, propose CAPAs, identify gaps, and leverage opportunities
• Promote operating excellence and innovation
• Contribute to Clinical Operations strategy and performance against key metrics
• Mentor and manage junior staff and Clinical Research Associates
• Act as escalation point for CRA site-related issues
• Conduct mid-year and year-end performance appraisals for direct reports

Clinical Research Manager

• Build and maintain a strong intellectual property portfolio supporting R&D, manufacturing and commercialization of biologics products
• Serve as a strategic partner to senior leaders in discovery, research, manufacturing and development on patent, regulatory data exclusivity, trademark and other IP issues
• Support corporate development, business development and research collaborations, including due diligence, contract drafting and negotiation, and alliance management
• Monitor patent trends and case law developments in the US and major markets and adjust IP strategies
• Advocate BeOne Medicines’ positions on IP government and regulatory policy matters
• Conduct patent and prior art searches, competitive landscape analysis, patentability analysis and freedom-to-operate analysis
• Review draft publications and presentations
• Provide litigation support, including validity and non-infringement analysis

Director, Senior IP Counsel

• Provide inspirational leadership, proactive management, and feedback-oriented mentorship to clinical study managers
• Lead assigned clinical study portfolios and designated therapeutic areas or assets
• Deliver regional studies or portfolios with inspection readiness, within agreed timelines and budget
• Act as regional lead for studies across indications or programs
• Lead regional clinical operations teams and serve as escalation point for regional issues
• Align regional resources and deliverables with portfolio goals
• Develop regional tools, work instructions, and SOPs
• Lead regional clinical operations strategy and decision-making
• Collaborate with regional stakeholders and provide portfolio progress updates to senior management and Global Clinical Study Managers
• Lead cross-departmental teams and develop cross-functional strategies
• Oversee clinical study planning and management from feasibility through closeout
• Optimize trial feasibility, country allocation, and site selection
• Coach and mentor regional study managers and CRAs
• Provide regional input on clinical supplies, drug inventories, labels, regulatory approvals, and comparator reimbursement
• Drive regional data collection, data entry, and query resolution
• Oversee Clinical Study Report planning and execution as required
• Ensure compliance with protocols, SOPs, ICH/GCP, and applicable regulations
• Maintain inspection readiness throughout the study lifecycle
• Manage regional vendor needs, investigator fees, site payments, patient travel reimbursement, resources, headcount, and budgets
• Interview, line manage, and evaluate regional clinical study managers
• Conduct performance appraisals and support professional development plans

Senior Director, Regional Clinical Study Management

• Provide the requirements and own the quantitative and analytical backbone for R&D portfolio prioritization, valuation, and analytical interpretation
• Support portfolio strategy in maintaining and refining portfolio information through involvement with project teams, R&D and commercial leadership, governance committees, Finance, Forecasting, and Competitive Intelligence
• Integrate probability of success, timelines, scenarios, sensitivity analyses, platform approaches, asset and disease strategy, and franchise perspectives into portfolio reporting
• Contextualize internal R&D portfolio data with industry benchmarks and competitive intelligence
• Partner with GPPM Systems and Reporting, Finance, and Pipeline Strategy and Valuation to provide insights for dashboards, predictive models, scenario simulators, and automated competitive or landscape signal feeds
• Own the analytics layer of the portfolio governance process and ensure committee materials use a consistent, reusable model
• Support emerging AI-enabled approaches, including predictive analytics, automated assumption-flagging, and natural-language synthesis of competitive intelligence
• Translate quantitative model output into committee-ready narratives and visualizations for senior R&D and Commercial leadership
• Support structured portfolio prioritization review sessions and integrate analytics into deliberations
• Serve as a methodological resource preparing valuation and risk inputs for governance review
• Collaborate with Program Management, Systems and Reporting, R&D Finance, and Global Commercial Strategy & Operations
• Bridge technical/data science capabilities with strategic and governance-facing portfolio needs

Regional Clinical Study Manager

Associate Director, Regional Clinical Study Management

Regional Clinical Study Manager

Senior Director, Regulatory Affairs

Director, R&D Counsel, Europe – New Markets

Senior Manager, Regulatory Affairs

Senior Global Clinical Process Management Specialist

Associate Director, Early Patient Engagement, Professional Societies

Account Executive

Director, Global Commercial, Tacabrutideg

Study Start-up Specialist

Clinical Research Manager

Director, Senior IP Counsel

Senior Director, Regional Clinical Study Management

Associate Director, Portfolio Strategy