全球临床流程管理主管
Director, Global Clinical Process Management Lead
关于我们
BeOne 是一家全球肿瘤公司,正在发现和开发更具成本效益且可及性更高的癌症治疗方案,为全球癌症患者提供帮助。凭借广泛的产品组合,我们通过内部能力和合作加速多样化疗法管线的开发。我们致力于大幅改善更多需要药物的患者对药品的可及性。我们的全球团队超过 10,000 名同事遍布五大洲,在巴塞尔、北京和美国剑桥设有行政办公室。如需了解更多关于 BeOne 的信息,请访问 www.beonemedicines.com 并在 LinkedIn 和 X(前身为 Twitter)上关注我们。
BeOne 正以快速的速度持续增长,为经验丰富的专业人士提供具有挑战性和令人兴奋的机会。在考虑候选人时,我们寻找具有高度积极性、协作精神,并且最重要的是,与我们一样对抗击癌症充满热情的科学和商业专业人才。
职位描述:
职位概述:
全球临床流程管理负责人负责领导和支持全球临床运营中的全球临床流程管理工作。与全球 GCO 利益相关方协作,该职位推动 GCO 内高效、一致、可持续且符合监管要求的流程和标准,同时支持能够加强流程的创新想法,并确保从概念到实施的有效对齐和跟进。该职位还确保与 ICH-GCP 和适用的监管要求保持一致。
职责:
- 为 GCO 内的全球临床流程管理工作提供战略支持,以促进 GCO 流程和标准在效率、一致性、可持续性和符合适用监管要求方面的提升。
- 作为 GCOE 在一个或多个 GCO 流程中的主要联系人,包括标准操作规程(SOPs)、工作指令和相关标准。
- 参与内容开发,并与 GCO 全球流程负责人和主题专家合作,或根据需要担任全球流程负责人,进行 GCO 程序文件的技术写作,包括标准操作规程(SOPs)、工作指令、模板和工具。
- 与 GCPC 协作开展 GCO 流程管理工作,包括评估修订或创建受控文件的必要性,并支持持续改进、变更管理和实施活动。
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About us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing,and Cambridge, U.S. To learn more about BeOne, please visitwww.beonemedicines.comand follow us on LinkedIn and X (formerly known as Twitter).
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.
Job Description:
General Description:
The Global Clinical Process Management Lead is responsible for leading and supporting global clinical process management activities within Global Clinical Operations. Working collaboratively with GCO stakeholders globally, this role promotes efficient, consistent, sustainable, and compliant processes and standards across GCO, while supporting innovative ideas that strengthen processes and ensuring effective alignment and follow-through from concept through implementation. The role also ensures alignment with ICH-GCP and applicable regulatory requirements.
Responsibilities:
- Provide strategic support for global clinical process management activities within GCO to promote efficiency, consistency, sustainability, and compliance with applicable regulatory requirements across GCO processes and standards.
- Serve as the primary GCOE point of contact for one or more GCO processes, including SOPs, Work Instructions, and related standards.
- Contribute to content development and collaborate with GCO Global Process Owners and Subject Matter Experts, or act as the Global Process Owner as appropriate, in the technical writing of GCO procedural documents, including SOPs, Work Instructions, templates, and tools.
- Lead GCO process management initiatives in collaboration with GCPC, including assessing the need to revise or create controlled documents and supporting continuous improvement, change management, and implementation activities.
- Identify, support, and help advance innovative ideas that improve GCO processes, enabling effective evaluation, stakeholder alignment, and follow-through from concept through implementation.
- Lead document review and approval workflows.
- Advise on and review processes owned by other functions that impact GCO processes and related standards.
- Establish and maintain effective partnerships with relevant GCO and cross-functional groups, including GCP Compliance, Learning and Development, and other stakeholders as needed.
- Contribute to the development and strategic direction of training materials related to GCO processes.
Supervisory Responsibilities:
- Matrix supervisory
Qualification Required:
Education Required:
Bachelor’s degree required, Master’s or other relevant post graduate qualification preferred.
Other Qualifications:
- Relevant Bachelor’s degree minimum – preferred science/healthcare discipline
- Typically 12 or more years of progressive experience in the pharmaceutical, biotechnology, or clinical research sector.
- Demonstrated experience leading complex global or regional clinical operations programs, process portfolios, or enterprise-wide improvement initiatives in a matrix organization.
- Expert knowledge of clinical operations processes, ICH-GCP, clinical trial regulations, inspection readiness, and compliance expectations, with the ability to translate requirements into practical global standards.
- Proven experience in end-to-end process design, governance, harmonization, optimization, implementation, adoption, and lifecycle management.
- Demonstrated ability to operate as a Global Process Owner, senior process lead, or trusted advisor to senior stakeholders, with strong judgement and accountability for outcomes.
- Strong change management capability, including stakeholder engagement, communication, training strategy, implementation planning, and sustainment.
- Excellent influencing, facilitation, negotiation, problem-solving skill.
- Strong analytical and risk-based decision-making skills, with experience using data and performance measures to evaluate process effectiveness and drive improvement.
- Excellent written and verbal communication skills, with the ability to present complex topics clearly to both technical and executive audiences.
- Demonstrated commitment to quality, operational excellence, collaboration, and continuous improvement.
Travel:
· According to the requirements.
What We Offer To Our Valued Employees
- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant!)
- In-house and external learning and development opportunities
- Fantastic benefits program and keep improving!
- Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
- Join us and Make momentum in your career!
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
BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy ().
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us.
Originally posted on Himalayas