BeiGene jobs - 83 jobs

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Maintains detailed records of work and creates and maintains internal libraries and databases, while also remaining informed of current scientific and clinical research being conducted. Independently or under supervision of line manager, follow up the process of clinical trial timeline, convey the information from other teams in time, ensure the site selection and site set-up going smoothly, and support clinical trial team to complete the patient enrolment plan. Support cross-functional meetings and prepare relevant meeting materials. Resolve the feasibility issues during site selection of clinical trials. Optimize and improve the quality of feasibility related data resources and materials. Essential Functions of the job: Participate in activities associated with Country Feasibility and/or Site Feasibility for regional and country clinical trials for the larger or more complex trial opportunities. Assist in securing site partnerships and alliances to improve the experiences of our customers and the patients. Supports non-clinical trial activities such as site business strategy, infrastructure, and capabilities, contributing to patient recruitment and performance outcomes for assigned sites. Identifies, analyses, and describes the competing clinical trial landscape in order to assist in assessing trial feasibility; draws conclusions and makes recommendations in text document (with supporting graphs, maps, and references) to be included in the feasibility report or therapeutic background section of the proposal. Additionally, findings are communicated in strategy meetings with management. Assesses the needs for external (e.g., past performances, business/competitive intelligence, disease epidemiology) and internal data (e.g. past performance, strategic priorities) for each clinical, defines the data requirements and procures the data from the pre-selected preferred service providers Support clinical trial efforts through data mining of internal databases, review of investigators for quality assurance and development of prioritize site list based on historic site performance and capability Provide information such as disease prevalence, BeOne Medicines' experience in various therapeutic areas, standard of care, availability / registration status / reimbursement status / price of drugs etc. to relevant parties as necessary or upon request, support the management on the timeline plan interevent clinical trails Reconcile and interpret feasibility data. Extrapolate data collected to provide a country-level assessment. Provide accurate, robust and realistic recommendations for country site numbers, recruitment rates, timelines and screen failure rates by working with the Site engagement Leads and commercial team if needed May liaise with internal and external customers to coordinate the collection and delivery of feasibility data. Set up the feasibility questionnaire template per clinical trial Manage the investigator database entry and quality, ensuring complete investigator and site information is captured, monitor for duplicate entries. Track all communications with sites in BeOne Medicine Databases, ensure status of documents is updated in real time Works closely with members of the management team and clients to negotiate scope of work to be performed for a clinical trial. Works closely with internal functions to ensure that site performance, recruitment metrics and benchmark data are systematically collected, stored and utilized regularly. Required Education/Experience: BA, BS preferred. Relevant job experience may be accepted in lieu of a degree in a related field. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $76,200.00 - $101,200.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Lead the Central Statistical Monitoring (CSM) team within the Global Statistics department to support the RBQM: providing statistical design, interpretation, and governance for monitoring activities that protect subject safety, ensure data integrity, and support trial reliability across BeOne's clinical development portfolios. Accountable for development, validation, and operationalization of statistical monitoring indicators and models across one or multiple studies/programs. Acts as the CSM statistician interfacing with clinical study statisticians, medical monitors, safety/pharmacovigilance, global clinical operations (GCO), quality/GCP, data management to ensure signals are interpretable, actionable, and compliance. RBQM statistical playbook; signal triage decision trees; standardized signal report templates; training materials for cross‑functional stakeholders; performance dashboards tracking signal investigation metrics. In collaboration with governance bodies, defines statistical thresholds, signal characterization methods, and recommended investigative workflows. Escalates safety or major data integrity concerns to medical monitors, safety leadership, and quality with rationale. Essential Functions of the Job: Design and validation of monitoring analytics Develop and maintain statistical risk indicators (KRIs), anomaly detection methods, and monitoring tool appropriate for study purpose and data flows. Partner with study team to specify data derivations, edit checks, and analytic data snapshots required by CSM algorithms. Validate models and algorithms: assumptions, diagnostics, false positive/negative rates, sensitivity analyses, and reproducibility. Signal detection, characterization, and prioritization: Implement processes to detect candidate signals across sites, subjects, and data domains (safety, efficacy, conduct, data quality). Characterize signals by magnitude, specificity, temporal dynamics, covariate dependence, and uncertainty; provide quantitative rationale for prioritization. Define and apply confidence thresholds, tiering logic (e.g., high/medium/low), and criteria for automatic alerts versus human triage. Cross‑functional interpretation and communication: Produce tiered deliverables: one‑line headline for executives, concise operational briefs for GCO, and detailed technical appendices for analytic teams. Translate statistical uncertainty and model assumptions into concrete, pragmatic next actions for operations and clinical follow‑up for medical monitors. Operationalization and decision logic: Co‑design decision trees, playbooks mapping signal types to investigative workflows, escalation paths, and CAPA triggers. Ensure feedback loops: incorporate investigation outcomes (true/false/insufficient) to recalibrate models and to improve data collection or derivation rules. Participate in RBQM governance meetings to align statistical approaches with study risk tolerances and regulatory expectations. Training, governance, and stakeholder enablement: Develop and deliver training modules for clinical monitors, safety officers, DM staff, and study teams on interpreting CSM outputs and on required actions. Provide statistical support during audits/inspections and contribute to CAPA design when monitoring uncovers systemic issues. Act as a change agent: promote a risk‑based mindset, help define governance criteria, and support SOP updates. Performance monitoring and continuous improvement: Define KPIs for CSM effectiveness: time‑to‑investigation, confirmation rate, and downstream corrective actions. Monitor performance dashboards, conduct periodic reviews, and implement improvements to models, thresholds, and communication templates. Supervisory Responsibilities: Yes Required background: Master's degree with 6 years' experience or Ph.D with 4 years' experience in biostatistics/statistics or related quantitative field. Demonstrated experience in clinical trial statistics RBQM/CSM, and signal triage. Strong stakeholder management and communication skills Experience with model lifecycle management, validation, and documentation for audits/inspections Computer Skills: Microsoft Office, PowerBI Other Qualifications: N/A Travel: Occasionally travelling is expected Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $162,600.00 - $212,600.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. 6-month contract due to an increase of new positions in our Global Clinical Operations team. General Description: This Recruiter needs to be a strong consultant with the demonstrated ability to understand Talent Acquisition requirements and turn that analysis into actionable solutions. A fundamental understanding of business strategy and how to link that with recruiting efforts. This role requires the candidate to be both strategic and tactical. Essential Functions of the job: End-to-end management of the recruiting process. In partnership with the recruiting team, HRBPs, and hiring managers, develops job descriptions, sources candidates, and drives the recruiting process for teams that they support. Pre-screen resumes, complete candidate evaluations, and schedule interviews for key positions. Must have the ability to recruit passive candidates. Delivers against and provides guidance to continually deliver quality candidates and hires. Drives adoption of consistent recruiting, interviewing, and hiring practices across the organization to facilitate talent acquisition productivity and predictable quality. Develops creative sourcing strategies for hard-to-fill positions, including direct sourcing, internet recruiting, networking, utilization of external search firms, etc. Assess internal and external recruiting resources and recommend solutions that will best meet the recruiting demands of the organization. Ensures recruiting and hiring practices are in compliance with government regulations and organizational policies and procedures in the pre-screening and post-employment process. Maintains current knowledge in business, marketplace, legal, and recruitment trends and requirements. Identifies and shares best recruitment best-practices across the organization. Initiates and maintains a network of contacts to help identify qualified candidates and increase applicant pool for hiring needs. Ensures end-user education and training (hiring managers) within the business. Knowledge, Experience, and Skills: At least 5 years' experience in recruiting in the Biopharma industry across multiple functions required. Bachelor's Degree preferred. Recruitment in Clinical Operations preferred. Previous experience supporting clinical research, commercial and business-related functions is a plus. Solid understanding of the pharmaceutical drug discovery lifecycle is a plus. Excellent communication skills, including presentation skills. Ability to gain credibility, engender trust, and influence across all levels of the organization. Strong partnering skills, bias for action and tangible results. Ability to follow assignments through to completion with an emphasis towards action and execution. Extensive experience leading recruitment activities Demonstrated experience in developing and implementing recruitment strategies, marketing plans, policies, and programs. Experience using applicant tracking systems (ATS), Workday experience is a plus. Experience working in a global environment. Supervisory Responsibilities: N/A Computer Skills: PC, including MS Office Suite, Workday Travel: None (Remote) Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $ - $ per hour BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. Physicians in this role are also expected to provide medical safety assessment. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders are important capabilities for this role. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams. Essential Functions of the Job: Signal and Safety Data Evaluation Lead the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile. Define data acquisition strategy, methodology, and approach for safety evaluations. Perform analysis of safety data and lead authoring of safety assessment Drive collaboration with PSLs, Safety Scientists, Pharmacoepidemiologists, and cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy. Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendation for action and initiate proposal for Safety Management Team Lead the preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB) Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions. Apply effective communication skills to lead and facilitate safety team meetings and drive decision making. Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner. Lead the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator's Brochure, Healthcare Professional communications (DHCP letter or DHPC), Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members. Lead signal assessment documentation following BeiGene signal management and safety governance framework. Clinical Trial Support Lead the review of safety data and monitor the safety of patients on allocated clinical trials. Lead the writing and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, Safety Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees. Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members. Lead the authoring of Storyboards and Briefing Books for HA interactions. Support ad-hoc review of the Safety Management Plans. Lead Safety Science specific investigator training. Risk Assessment, Regulatory Inquiries, and Periodic Reporting. Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug. Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Periodic Safety. Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs). Lead and demonstrate ability to resource, plan, and fulfill additional evaluation requests with quality from health authorities (e.g., PRAC PSUSA) for assigned compounds. Identify safety related questions from the review of inquiries and assess the impact to applicable safety documents or safety section of clinical or regulatory documents. Lead strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs. Author Health Hazard Evaluations Contribute to integrated Benefit/Risk assessments. Promote and Advance the Field of Pharmacovigilance Responsible for effective execution, communication and influence with internal stakeholders (e.g., clinical development, medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies). Contribute to continuous employee development programs, such as mentoring, coaching, and peer-to-peer learning. Contribute to and provide Safety Science training to support team development. Identify and develop innovative approaches to continuously improve organizational effectiveness and productivity. Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are high in complexity. Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with internal processes, local laws and regulations. Execute any other tasks assigned by manager to assist in departmental activities. Supervisory Responsibilities: This position may have direct reports depending on the program / portfolio being led. The Director, Safety Scientist provides key support as an experienced safety scientist that leads and performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely with the Safety Science group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations and provides a high degree of support to assigned compounds and line manager. Computer Skills: Advanced knowledge working with a safety database (i.e., Argus) for retrieval of safety information. Advanced knowledge of MedDRA and signal management system Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva) Advanced knowledge of data mining tools and analyses tools such as Spotfire and PowerBI Other Qualifications: Prior matrix management team experience Clinical knowledge of various disease states, drug effects, human physiology and pharmacology Demonstrated ability to prioritize and manage multiple deliverables simultaneously. Demonstrated leadership, organizational and administrative skills. Prior experience with Regulatory Agency interactions Pharmaceutical product development experience, including individual study design and filing plans. Experienced in global regulatory requirements for pharmacovigilance. Education Required: PharmD, NP, RN, or PhD in a medical field or biological science and 8+ years of experience as a Safety (Pharmacovigilance) Scientist. MD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring. 4+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine and 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred Travel: Less than 10% Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $185,100.00 - $245,100.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. *Open to AD or D level candidates. General Description: Leveraging deep Therapeutic Area expertise, solid global program management skills, global view, and borderless leadership, the GCO Program Lead is accountable for the strategic operational planning and clinical operational performance, of designated programs and acts as a point of escalation for the resolution of issues of the studies within responsible program(s). Lead the gCSMs in designated programs, provide inspirational leadership, facilitate proactive risk and issue management, and deliver feedback-oriented mentorship to the gCSM line reports, fostering talent development. Partner with other program leads/functional representatives in BeOne R&D to drive disease/asset strategy and ensure execution excellence by contributing clinical operations insights and expertise at the program level. This is an international role and requires working with colleagues in various time zones. Essential Functions of the job: Strategic leadership and management Accountable and responsible for building, developing and retaining the global team of gCSM, including hiring, training, mentoring, developing direct and indirect reports, performance appraisals and resource management. Oversee the delivery and goal achievement of projects within the designated program(s), serving as the point of escalation for resolving issues that gCSM cannot resolve. Collaborate with the other GCPLs to define and implement strategies and key priorities across-programs, and establish global standards for goals, performance measures, and capability development for the gCSM roles. GCO Representative for the designated program(s) In coordination with Franchise Head, Accountable to the Franchise ERC, DCT and other governance teams as appropriate as GCO representative, to provide clinical operational insight to drive the program strategy and ensure excellence in execution. Lead/participate in the KOL engagement activities in the designated programs and may act as function spokesperson if needed. Program Management Evaluate and develop strategic feasibility and budget estimates during Early Planning for new CDPs and upon strategy change during the conduct of a study, where needed. Accountable for resource allocation and initiating CST formation; ensures appropriate transition of outputs from early planning to the gCSM. Create and be accountable for the annual program budget and resource forecasts, as well as contributing to and tracking the relevant DCT goals for the program. Create, review, and provide input to and maintain compound-level documents such as IB, DSUR, and protocol. Oversee timely, quality, and efficient study planning and execution of associated studies within the allocated program. Conduct regular program review meetings to mentor, support, and ensure all studies are tracking to the DCT/DRC-approved budget and timeline. Report on study status, goals, and operational KPIs, and enforce quality KPIs with support from the Compliance team. Collaborate with other GCPLs to evaluate and designate preferred global vendors and participate in vendor governance meetings. Create or review performance and development plans for direct reports, facilitate and support delivery of performance and development goals. Provide line management and mentorship to gCSMs working within the designated program(s). Inspire and lead efforts to deepen scientific knowledge within the Clinical Operations' function. Champions a global mindset and approach across Clinical Operations to foster collaboration and consistency across the organization. Provide expert knowledge on the execution of clinical trials through a deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements. Point of escalation for all compound-related issues. Identify and drive process improvement initiatives in collaboration with Franchise Head and/or other GCPLs within program. Collaborates with cross-functional leaders to provide operational perspectives to enable effective and efficient delivery of clinical development goals. Supervisory Responsibilities: Line managing direct reports Computer Skills: Microsoft Office Other Qualifications: Project management exposure/experience across the entire lifecycle of multi-region/country clinical trials in a fast-paced global environment. Experience in both people management and program management preferred. Travel: Travel might be required as per business need. Education/Experience Required: Bachelor or higher degree in a scientific or healthcare discipline with 10+ years' experience in clinical trial industry. Technical Skills Transferrable Skills across GCO Continuous Improvement: Data Analysis, Issue Resolution, Quality Management, Regulatory Compliance, Root Cause Analysis, Schedule Management, Training Technical Skills for program and study management •Clinical Documentation and Records Management •Clinical Operations Management •Contract Management •Data Management •Feasibility Studies •Project / Program Design •Project / Program Management •Risk Management •Technical Reporting •Resource Management Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $171,900.00 - $231,900.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. We seek motivated professional to contribute our clinical operation data analytics initiatives. This role focuses on delivering advanced analytics and insights that drive strategic decision-making and operational efficiencies across our portfolio. The ideal candidate will possess a strong understanding of data science principles, business acumen, and the ability to collaborate with various stakeholders to translate business needs into actionable analytics. Data Analytics & Interpretation: Implement analytical insight strategy aligned with business stakeholders across the portfolio Deliver in-depth analyses and predictive modeling that provide critical insights to management and leadership teams Utilize advanced analytics, machine learning, and artificial intelligence techniques to identify trends, patterns, and opportunities within complex datasets, directly applying these capabilities to address business challenges. Ensure the accuracy, integrity, and security of data to meet compliance standards and regulatory requirements. Stakeholder Engagement: Effectively translate business and cross-functional questions into well-structure analyses with actionable recommendations. Gain a profound understanding of business processes and exhibit strong business acumen to deliver actionable analytics Collaborate with product managers and business functions to define KPIs, OKRs, metrics that measure trial execution success (e.g., cycle time, site activation, enrollment trends, deviation rates, site financials), develop and implement role-based dashboards or analytical tools to track business operations, performance and suggest data-driven next best actions. Innovation and Continuous Improvement: Hands-on experience in implementation and operationalizing AI/ML solutions in business context, technically proficient in various algorithms and models Identify and improve processes continuously, explore the opportunities of doing things differently and smartly Education/Experience Required: Master's or PhD in Data Science, Statistics, Computer Science, Life Sciences, or a related field 1+ years of experience in data analytics, insights, or related fields Familiar with clinical systems, e.g., EDC, CTMS, IRT and other systems Strong proficiency in data analysis tools, visualization tools and programming languages, such as Python, R, SQL, or similar. Experience with data visualization tools (e.g., PowerBI, Spotfire) and familiarity with cloud platforms Hands-on experience with AI/ML to develop algorithms in business context. Familiarity with Agentic AI is a plus Strong capability of prioritizing and handling multitasks, executing quickly Be able to work under pressure Exceptional analytical, problem-solving, and critical-thinking skills Self-motivator, hands-on, disciplined and proactive person with great team-work spirit and strong accountability Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $105,600.00 - $140,600.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Education Required: Currently enrolled students (cannot graduate prior to September 2026) and have complete at least two semesters of graduate work towards a M.S. or PhD degree in Statistics or Biostatistics by May 2026. Ph.D. candidate preferred. General Description/Scope of Responsibilities (Internship): The biostatistics intern will participate in statistics methodology research to support drug development under the guidance and mentorship of biostatisticians in the Global Statistics & Data Science Group. Essential Functions of the Internship: The intern will conduct one or more of the following: Literature review Development of innovative statistical methods if necessary Creating SAS macro/ R packages/R shiny for statistical analyses if applicable Computer simulations Strong or prior experience in survival data modelling and simulation Computer Skills: R and (or) SAS Other Qualifications (one or more): Effective oral and written communication skills. Bayesian statistics knowledge or course work preferred. Knowledge of causal inference, meta-analysis, and survival models preferred. R package and/or R shiny development experience preferred. experience with JAGS, Stan, or BUGS preferred. Travel: < 10% Pay Rates: Masters: $30/hour USD PhD: $35/hour USD Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $ - $ per hour BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

Reporting to Sr. Director of Sales for the division, the Regional Sales Director (RSD), Northwest will lead, coach, motivate, and inspire a diverse team of Clinical Sales Specialists (CSS) who are responsible for compliantly educating Healthcare Providers and their staff on recurrent pericarditis and treatment with Arcalyst for eligible and appropriate patients. The RSD will lead in execution of customer targeting and account planning across the assigned region to maximize the customer and patient experience and deliver on business opportunities for Kiniksa. The Regional Sales Director, Northwest will support Kiniksa's objective of building a generational company and sharing in our mission to make every second count for patients and our business. A successful RSD must possess excellent leadership capabilities with an ability to inspire, coach, and maintain a high standard of excellence. Commercial aptitude, clinical acumen, and strategic agility will be required to achieve our goals. Responsibilities (including, but not limited to): * Recruit, onboard, train, develop, retain, and coach a diverse team of 8-10 CSSs * Proactively contribute to provide field insights for input to the strategic and tactical plan * Lead team to flawlessly execute our priorities * Achieve all regional sales goals and targets * Lead region and territory business planning * Provide feedback to the business on improvements to our sales and marketing strategy * Monitor regional expense budgets to ensure compliance and optimal use of resources * Partner with Though Leader Liaisons to cultivate and develop compliant professional business objectives that support our strategy with thought leaders and key institutions * Translate Kiniksa's corporate objectives and business insights and analytics into specific, measurable, and executable action plans for direct reports * Coach and develop CSSs through consistent and regular field visits, one-to-one business and professional development discussions, and other communications * Continuous track, monitor, and report on sales performance and progress * Evaluate the performance of direct reports, providing clear expectations and specific behavior-based feedback * Foster collaboration across internal stakeholders * Comply with all laws, regulations, and policies that govern the conduct of Kiniksa activities * Business travel, by air or car is required approx. 75-80% work week Qualifications and Experience: * Bachelor's Degree Required * 10+ years' experience leading a pharmaceutical / biotechnology sales team * Desire to work in a fast-paced, highly collaborative, team environment * Cardiology and/or rheumatology experience strongly preferred * Rare disease experience strongly preferred * Experience with injectables is preferred * Experience with specialty pharmacy and HUB dynamics for patient access is a must * Must demonstrate knowledge of reimbursement and healthcare environment trends * Proven record of consistently exceeding financial and/or other quantitative targets, as well as qualitative goals * Experience in Marketing, Sales Operations, or other support functions is a plus * Excellent communications skills demonstrated by ability to translate strategy into execution * Must possess an understanding of external laws, codes, and company policies that apply to the healthcare industry * Salary is commensurate with experience * Kiniksa Benefits Summary - USA The expected salary range for Regional Sales Director is $230,000 - $250,000 annually. Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks. In addition to base pay, this role includes a Sales Incentive plan. Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Reporting to the Head of DS Manufacturing Cell Culture. This position plays a leading role in troubleshooting processes, building a detailed understanding of them, and driving process robustness and meeting manufacturing timelines by setting clear objectives and empowering their team. This position involves consistent collaboration with Cell Culture MSAT, DS Manufacturing Purification, Facilities & Engineering, Quality Control, Quality Assurance, Regulatory groups. This position requires through knowledge in mammalian cell culture processes and some exposure to protein purification and protein product quality attributes. Of equal importance is the ability to lead and develop reports. Essential Functions of the Job: Leading, mentoring and development of staff is a critical part of the responsibility, with an aim to empower team members to a level commensurate with their skills and experience. Participate in cross-functional projects teams Ensure a safe working environment Effective communication with team members and stakeholders is a must Participate in and support on-site supervision and management of contract manufacturers as required by BeiGene. Technical Skills/Knowledge: CIP & SIP of fixed stainless-steel vessels and transfer lines Solution preparation and transfer Single Use Technologies (mixers & bioreactors) Seed lab operations: passaging and scale-up Bioreactor wave and shaker flask Bioreactor operations Harvest operations Sterile Filtration / Integrity testing Analytical Instrumentation (pH, osmometer etc.) Good Documentation Practices Equipment and process troubleshooting Authoring SOP's, MBR's & WI's Delivering technical presentations Quality Risk Assessments Health Authority Interaction/Audits Resource Modeling OE and/or LEAN Methodologies Distributed Control system / Control Systems Deviations, assessments, investigations & CAPA's SAP, LIMS, CMMS, Veeva Education / Experience Required: BA/BS or higher in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline. Minimum of 2+ years of experience in the Life Science/Biotechnology. Minimum of 1+ years supervisory experience in biopharma industry Knowledge of GMP & GDP drug preclinical, clinical and commercial requirements. Familiarity with EMA and FDA regulatory requirements. Effective communication, oral and written, in a multi-disciplinary, project-driven work environment. Supervisory Responsibilities: Strategic and tactical planning with ability to convey business relevance to team Ability to translate strategy into actionable goals and expectations for team members Consistently delivers tangible business that support organizational objectives via self and direct reports Leading, directing, coaching/developing, and providing timely feedback to direct reports Planning and managing day to day activities, including staff availability and task load Writing and delivering effective performance appraisals Consistently receives and provides feedback thoughtfully Self-directed leadership within both predicable and ambiguous work environments Inclusive and cross-functional collaboration with all levels Ability to cultivate culture of continuous improvement and right first-time quality Thoughtfully escalates issues/concerns in a timely manner as appropriate Project management and working through competing priorities Recruiting, interviewing, and selecting key talent Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). Other Qualifications: N/A Travel: Some travel may occur as a result of duties assigned to the role, up to 20% Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $83,500.00 - $113,500.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Opportunity: Part-time /Internship Education Required: Currently enrolled in a Master or PhD program General Description/Scope of Responsibilities (Internship): Open to pharmaceutical scientists and AI engineers eager to apply advanced analytics to drive innovation in drug development This internship program is to provide intern exposure to the field of clinical pharmacology and various modeling and simulation tools used to support drug development, including scientific machine learning pharmacodynamic models and autoencoder generative machine learning model Under the supervision of the manager, the intern will have an opportunity to apply AI/Machine Learning or Large Language Model to work with large clinical datasets, and to participate in developing a predictive model. Develop proficiency in the use of software tools for the development of PBPK, PK/PD models and the R programming language for data management Attend Department meetings to gain exposure to drug development process Flexible start date Remote or on-site options available Essential Functions of the Internship: Literature review and data management: Review and capture literature source for used in the modeling; transform raw clinical datasets into a format that makes it valuable for downstream analysis. Model development, verification and validation: learn how to develop semi-mechanistic models to support drug development; learn how to apply AI/large Language Model to support the analysis and reporting in accelerated drug development. Supervisory Responsibilities: No Computer Skills: Familiar with R or Python and experience in data analysis using AI/Large Language Model is ideal. Other Qualifications: Course work in AI and Data Science Travel: None Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $ - $ per hour BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The Executive Director, Global Infrastructure and Cloud Computing is a key leader in the GTS Enterprise Technology and Architecture team. They will lead the strategy, design, and delivery of enterprise infrastructure, network and cloud services across our global organization. This role is responsible for ensuring secure, scalable, and cost-effective technology platforms that enable business growth and innovation. The position requires deep technical expertise, strong leadership, and the ability to drive transformation in a highly regulated environment. Essential Functions of the Job: Develop and execute the global infrastructure and cloud strategy aligned with business objectives. Oversee architecture, engineering, and operations for network, compute, storage, and cloud platforms. Lead compliance and optimization initiatives across AWS and Azure environments. Ensure high availability, disaster recovery, and performance monitoring for all infrastructure services across all BeOne operating regions. Drive automation and modernization initiatives using Infrastructure as Code (IaC) tools such as Terraform. Establish and maintain data center standards, including physical and virtual infrastructure best practices. Oversee system administration for enterprise servers, operating systems, and core infrastructure services. Implement proactive monitoring and observability frameworks to ensure reliability and rapid incident response. Manage vendor relationships and negotiate contracts for infrastructure and cloud services. Collaborate with cybersecurity, application development, and business teams to ensure seamless integration. Establish governance frameworks and performance metrics for infrastructure and cloud services. Mentor and develop a global team of engineers and architects. Partner with cybersecurity team to ensure the highest standards of security are applied and maintained to the technology stack. Partner with BeOne technology leaders and stakeholders to ensure technology stack supports business goals. Qualifications: Minimum 14+ years of experience in IT infrastructure and cloud computing, with at least 8 years in leadership roles. Proven expertise in AWS and Azure cloud platform management and architecture. Alicloud, Tencent experience is a plus. Strong background in network engineering, enterprise architecture, Terraform, system administration, and monitoring solutions. Demonstrated experience managing global infrastructure operations and large-scale cloud migrations. Excellent leadership, communication, and stakeholder management skills. Bachelor's degree in Computer Science, Information Technology, or related field (Master's preferred). Experience in biotech or pharmaceutical industry, with understanding of regulatory and compliance requirements. Familiarity with GxP, HIPAA, and other industry standards. Advanced certifications in cloud technologies (AWS Certified Solutions Architect, Azure Solutions Architect Expert). Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $278,200.00 - $358,200.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Regulatory Affairs Director Dx/CDx and Medical Devices will be responsible for leading a small team for developing and implementing regulatory diagnostic and medical device strategies, for the designated program(s) to support clinical trials where necessary, and facilitate marketing authorization in line with business objectives, and in coordination with key internal and external stakeholders. Essential Functions of the job: Develop US regulatory strategy for the designated program(s) and contribute to the clinical development plans to align diagnostic testing and drive integration to therapeutic development plans. Act as the representative of the US regulatory team at the global regulatory team (GRT) for the designated projects needing diagnostics, and may also be required to represent diagnostic strategies to global cross-functional teams on specific programs or for specific topics Drive the strategy, providing direction and oversight for Dx/CDx and Device related content of regulatory documents, such as assessments, regulatory memos, and briefing documents and responses, for interactions with US regulatory authorities, as applicable. Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of diagnostic submissions Oversee and be accountable for Dx/CDx and Device related regulatory agency communications, submissions, and approvals, with a quality focus to minimize cyclical review Lead and mentor team members Maintain up-to-date working knowledge of laws, regulations, and guidelines applicable to the US testing space. Represent BeOne's US Dx/CDx and MedDev regulatory function at industry consortium (may be required). Other Qualifications: Minimum BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry, and 5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge and substantial working experience, or 10+ years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years' experience in a Regulatory capacity with increasing responsibility. Seasoned negotiator, both internally and externally with a solid background in medical devices/diagnostic development regulations and associated regulatory deliverables. Experience working with various Health Authorities, primarily FDA, to support diagnostic testing. Sound understanding of the drug and diagnostic development process, the pharmaceutical industry and healthcare environment including Global and US regulatory requirements and policy trends Recent experience with diagnostic testing to support clinical trials in all phases of study, is mandatory for this role. Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism English native speaker is preferred Location: US (remote). Reports To: Executive Director, Global Regulatory Strategy, Dx/CDx and Medical Devices. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $176,000.00 - $236,000.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Perform QC Chemistry laboratory activities with a primary focus on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, and BeOne Medicines' processes and procedures. Essential Functions of the Job: Perform routine and non-routine testing using capillary electrophoresis techniques (e.g., CE-SDS, CZE, ic IEF) in the QC Chemistry laboratory to ensure timely and compliant generation and reporting of in-process, release, and stability test results in support of manufacturing operations. Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures. Lead troubleshooting efforts for analytical methods and instrumentation related to CE. Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays. Implement corrective actions and preventive actions (CAPAs). Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation. Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, test record keeping, etc. Maintain equipment in a qualified and calibrated state, coordinating with metrology or vendors as needed. Manage inventory of reagents and supplies for the laboratory. Participate in internal and external GMP audits, as needed. Train other junior level analysts and new hires on CE instrumentation, GMP practices, and data analysis. Serving as subject matter expert in one or more areas of required testing. Interacts with all levels of BeOne employees. Undertake other duties as required. Education/Experience Required: Bachelor's or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. Minimum of 4+ years of working experience in an FDA-regulated biotechnology, pharmaceutical company are required. Familiar with Waters Empower Chromatography Data System. Familiar with instrument and equipment validation. Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Working knowledge with USP/EP and cGMP/EU GMP regulations. Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Credible and confident communicator (written and verbal) at all levels. Strong analytical and problem-solving ability. Hands-on approach, with a ‘can do' attitude. Ability to prioritize, demonstrating good time management skills. Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. Self-motivated, with the ability to work proactively using own initiative. Committed to learning and development. Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). Travel: Must be willing to travel approximately 10%. Ability to work on a computer for extended periods of time. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $90,900.00 - $125,900.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The Medical Director, Hematology will support BeOne clinical assets and pipeline by successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. As a leader in the organization, the incumbent will be accountable to assess and execute clinical programs and help assure that activities are executed within expected scope, budget and timelines. The incumbent will play a key role the establishment and growth of Clinical Research functions to assure best-in-class global capabilities and execution. Specifically, the incumbent will work closely with colleagues in clinical development, program management, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research and other functions. Essential Functions of the job: Facilitate generation of, author, update, and/or review key documents, including, but not limited to: Protocol concepts, synopses, protocols, and amendments Informed consent documents Investigator Brochures Clinical study reports Abstracts, posters and manuscripts Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports Risks / benefits analysis for applicable documents Clinical Development Plans Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies Provide scientific expertise for selection of investigator and vendors Train BeOne colleagues, study site staff on the therapeutic area, molecule, and/or clinical protocol Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities Review, query, and analyze clinical trial data • Interpret, and present clinical trial data both internally and externally Represent a clinical study or development program on one or more teams or sub teams Create clinical study or program-related slide decks for internal and external use Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings Contribute to or perform therapeutic area/indication research and competitor analysis Build strong relationships with internal experts Identify continuous process improvement opportunities. Identify incremental organizational resource needs - staff, budget, and systems Develop, track, execute and report on goals and objectives Support budget planning and management Be accountable for compliant business practices Qualifications: Essential: MD (or equivalent medical degree); board certification or eligibility in relevant therapeutic area (e.g., oncology, hematology) Clinical training with experience in drug development or clinical research, ideally across Phases I-III Strong understanding of clinical trial design, GCP and regulatory environment for submissions (IND, CTA, NDA, BLA) Demonstrated safety oversight skills, familiarity with DSURs, PSURs, and safety committees Excellent communication skills, capable of engaging internal teams, external partners, and regulators. Preferred: Proven track record in therapeutic area development (hematology or oncology) Experience or familiar with translational medicine, PK/PD data integration, or biomarker strategies. Prior involvement with Life Cycle Management and commercial interfacing Global clinical trial experience across multiple geographies Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $249,800.00 - $309,800.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: This position is a critical role within the MST Cell Culture laboratories and activities may include but are not limited to Media Preparation, Inoculum, Seed/Production Cultivation and Harvest process, therefore previous experience is preferred. The position will be responsible for design and execution of laboratory experiments, data analysis and authoring of various reports. This position reports directly into the Associate Director, Manufacturing Science and Technology (MST) Cell Culture and is located at the Hopewell, NJ site. The position will support process improvements, troubleshooting, compliance related activities and provide technical support to Drug Substance manufacturing. Process monitoring and trend analysis of manufacturing operations will also be another key activity that will be required for the position. The position will be very involved with tech transfer activities through the lifecycle of a project which include gap and risk assessments, generating technical transfer plans, process descriptions and control strategies, related protocols and reports, and continuous process verification. Working in Cell Culture MST provides a unique growth opportunity for professional exposure to many facets of process development and drug substance manufacturing. This position involves close collaboration with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, Process Development groups and MST counter parts located in other sites and countries. In addition, as BeOne Hopewell continues to progress, many unique opportunities and challenges will occur for anyone who is looking for career advancement. Essential Job Functions: Participate in cross-functional projects teams that provide tech support to manufacturing and process development, and able to present data and study findings in coherent manner. Ensure a safe working environment. Responsible for execution of laboratory experiments and maintaining support laboratory activities. Author study protocols and reports, and other documentation supporting deviations and regulatory activities. Perform tech transfer activities, including facility gap and risk assessments. Provide technical support as SME for implementation of cell culture processes. Author technical transfer plans, process descriptions, control strategies, and campaign summary reports. Author Process validation plan, PPQ protocols, and various upstream study protocols to support PPQ. Perform Continued Process Verification (CPV) and process monitoring during campaigns. Effective communication with team members and stakeholders is a must. Serve as Person-In-Plant (PIP) during critical steps of the manufacturing process, when required. Perform manufacturing data analysis as required. Any other assignments as are determined by the manager. Education/Experience Required: BA/BS in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline with 2+ years of Life Science/Biotechnology experience required Knowledge of Mab Facilities and Process Design / Development. Knowledge of biopharmaceutical equipment qualification and Validation activities. Cell culture knowledge including inoculum processes, bioreactor systems, harvest processes and analytical equipment. Ability and aptitude for analyzing data, detecting inconsistencies, determining relative importance, and utilizing data, conducting root cause analysis, and risk management. Experience with tech transfer to clinical/commercial manufacturing facilities. Knowledge of study design such as DOE and authoring of study protocols / reports. Good understanding of GMP requirements. Proven planning and data analysis skills, use of statistical software to analyze data Project management skills related to internal and external teams Knowledge of regulations and guidelines of FDA, EMA, ICH, PDA. Demonstrated experience working in cell culture laboratory or equivalent. Knowledge of drug preclinical, clinical and commercial requirements. Familiarity with EMA and FDA regulatory requirements for submissions. Effective communication, oral and written, in a multi-disciplinary, project-driven work environment. Experience with software such as Microsoft Office, JMP or SAP. Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). JMP or equivalent SAP or equivalent Physical Requirements: Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently. Must be able to work scheduled 40 hours with the ability to work overtime as needed. Must be comfortable in working in varying temperatures. Ability to gown and work in manufacturing areas, when required. Some reaching, bending, stooping, and twisting Repetitive motion and substantial movement of the wrists, hands, and/or fingers. Environment requires dedicated gowns, depending on area. Work with potentially hazardous materials and chemicals. Willing to work off shift, when required. Travel: Some travel may occur as a result of duties assigned to the role, up to 20% Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $90,400.00 - $120,400.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Position Summary: Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget Acts as regional lead for multiple studies across an indication or across a program as required Leads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned study Ensures alignment of regional deliverables with overall study goals Contributes to the development of regional tools and leads the development of work instructions and SOPs as required Essential Functions of the job: Regional Leadership Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study Leads external vendors involved in study delivery on a regional level Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings Leads regional operations meetings with all regional study team members Displays therapeutic area knowledge and expertise Timelines, Planning and Execution Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders Provides regional input on global study plans as required Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs Ensures regional and country information in study systems and tools is entered and up to date Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular basis as per the study TMF QC plan Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region Manages the trial data collection process for the region, drives data entry and query resolution As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing Quality: Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations Ensures inspection readiness for study in region at any point in time throughout the study life cycle Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate Collaborates with CST members and othercolleagues to ensure cross-team, site learnings, and best practices are shared Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies Leads the development, optimization and review of work instructions and SOPs as required Budget and Resources Works with the sourcing team to select and manage regional study vendors Manages regional study budgets Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities Identifies and manages regional team resource needs and establishes contingency plans for key resources Monitors regional resource utilization over study life cyle and liaises with functional managers as needed Supervisory Responsibilities: Provides performance feedback on team members as required Mentors junior team members and might take on line management responsibilities as required Computer Skills: MS Office, Project Planning Applications Other Qualifications: 6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry Proven experience in clinical research including relevant experience as team lead in clinical functions Experience as CRA is preferred Travel: Travel might be required as per business need Education Required: Bachelor's Degree in a scientific or healthcare discipline required*, Higher Degree preferred *exceptions might be made for candidates with relevant clinical operations experience Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $136,400.00 - $181,400.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Oversees internal operations, supports the Americas Clinical Operations Head, and is an active member of the Clinical Operations Americas leadership team Provides leadership in finance and resource management, metrics development and review, and communications for the Americas Clinical Operations team Measures organizational health and proactively liaises with Americas Clinical Operations Head and with peers to discuss potential areas of concern Drives operational excellence, embeds innovation and continuous improvement, and drives a productivity mindset Leads or project manages key projects within Clinical Operations Americas or represents the Americas Clinical Operations team in global/cross functional projects Establishes and maintains effective communication and collaboration with functional area peers in the Global Clinical Operations Team (e.g. Global Strategic Operations) and other departments as well as other stakeholders both within the region as well as global. Essential Functions of the job: Acts as right hand of the Americas Clinical Operations Head, and is responsible for overseeing the internal operations for Clinical Operations Americas Creates and maintains systems, business processes and metrics to streamline internal operations within Clinical Operations Americas Forecasts and manages Clinical Operations Americas resources and budgets, in collaboration with key stakeholders. Reviews resource algorithms and performs resource gap analyses. Advises and facilitates resource deployment and reallocation across all teams and countries in the region. Oversees the Clinical Operations Americas functional budget, including regular review with stakeholders. Highlights budget changes, and calculates ROI where necessary Ensures regular review of metrics to evaluate organizational health. Participates in JOC meetings for oversight of partnership metrics. Highlights potential areas of concern proactively and works with key stakeholders to ensure mitigation plans are set up Tracks progress towards goals and key initiatives and works with Americas Clinical Operations Head to ensure timely and effective completion of these Drives productivity mindset through identification of areas for improvement and new ways of working Drives the development of presentations, and establishes practices to institute progress reports, progress review meetings, and other means for Clinical Operations Americas communication and collaborations Directs the coordination of Clinical Operations Americas leadership team meetings including meeting schedules, draft agendas, meeting minutes, action items Represents Clinical Operations Americas in collaborations with internal and external key stakeholders Establishes the Business & Strategic Operations function as integral part of Clinical Operations Americas Supervisory Responsibilities: Mentors team members as required, which includes providing constructive feedback. Computer Skills: MS Office, Project Planning Applications Other Qualifications: Experience with process improvement and process optimization initiatives, as well as implementation of new business models Strong written and verbal communication skills In depth knowledge of and experience with operational management, strong problem solving skills Proven ability to build strong effective relationships, demonstrated effective influencing and negotiation skills at all levels Ability to be flexible and willing to accept new responsibilities as needed as role and team evolves Exercises sound judgement and discretion in matters of significance Ability to work independently and effectively handle multiple priorities in a fast-paced environment Excellent interpersonal skills, strong organizational skills and ability to influence and lead Travel: Travel might be required as per business need. Education & Experience Required: Bachelor's degree in a scientific or healthcare discipline and 12+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. Preferably master's degree in a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $171,900.00 - $231,900.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Work with cross-functional study/project teams supporting hematology studies and interact with Clinical, Regulatory, Statistical Programming, Data Management and other Research Scientists in reviewing the data, developing and implementing the statistical analysis plan (SAP) for the clinical study report (CSR) and other health authority submission documents. Provides content for manuscripts / presentations and provides statistical support in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical projects. Essential Duties & Responsibilities: Develops or assists development of study protocols and SAPs and determines appropriate statistical methodology for data analysis. Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements. Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements. Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Applies and implements basic and complex techniques to these analyses under supervision. Prepares oral and written reports to effectively communicate results of clinical trials to the project team. Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators. Involved in research activities for innovative statistical methods and applications in clinical trial development. Other Qualifications: Experiences with clinical trials and knowledge of regulatory guidance are required. Oncology experience is preferred but not required. Demonstrated written and oral communication skills and ability to work within a team and work independently are required. Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability. Education Required: A minimum of a PhD in Statistics or related field with 4+ years of experience in clinical drug development is required. Knowledge of SAS and/or R is strongly desirable. Computer Skills: Knowledge of SAS and/or R is strongly desirable Travel: Not required BeOne Global Competencies: When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $162,600.00 - $212,600.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Manages all Quality Control (QC) Physicochemistry laboratory activities to support GMP manufacturing, testing and release of materials, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Physicochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at the Hopewell, NJ site. Essential Functions of the Job: Lead the QC Physicochemistry laboratory daily workflow. Establish and maintain QC Physicochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards. Manage QC Physicochemistry laboratory routine operations, including but not limited to validation, SOPs, specifications, testing records, personnel training and assessment, scheduling, etc. Ensure Physicochemistry laboratory compliance with Environmental Health and Safety (EHS) standards. Ensure timely completion of testing (e.g., In-process control, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations. Review of laboratory test results, ensuring adherence to Good Documentation Practices. Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures. Implementation of effective corrective actions and preventive actions (CAPAs). Participate in internal and external GMP audits where possible. Ensure that the QC Physicochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. Expertise in Quality Control (QC) within a Good Manufacturing Practice (GMP) environment, ensuring compliance with industry standards and regulations through hands-on laboratory experience. Working knowledge and experience with physicochemistry analytical methods such as GC, HPLC, UPLC, IEF, TOC, UV, FTIR, etc. Knowledgeable with USP/EP and cGMP/EU GMP regulations. Familiar with instrument and equipment validation. Expert knowledge of quality control principles, practices and standards for the biopharmaceutical industry. Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Strong leadership/team management skills and experience. Manage, motivate, coach and mentor direct reports. Credible and confident communicator (written and verbal) at all levels. Strong analytical, problem-solving ability, with excellent attention to detail, with the ability to work accurately in a busy and demanding environment. Excellent project management skills. Hands-on approach, with a ‘can do' attitude. Ability to prioritize, demonstrating good time management skills. Self-motivated, with the ability to work proactively using own initiative. Committed to learning and development. Interacts with all levels of BeOne employees Undertake any other duties as required. Supervisory Responsibilities: Manage direct reports from QC Physicochemistry laboratory. 2+ years of managerial experience directly managing people required. Leadership experience leading teams, projects, programs or directing the allocation of resources. Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). Ability to work on a computer for extended periods of time Travel: Must be willing to travel approximately 10% Education/Experience: Bachelor of Science degree and 5+ years of experience in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility required. Bachelor's in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, or related scientific discipline preferred. Master's degree and 4+ years of relative experience preferred. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $110,800.00 - $150,800.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.