General Description:

The role is responsible for leading and supporting global clinical process management activities within GCO, ensuring that processes, standards, and related procedural documents are efficient, consistent, sustainable, and compliant with applicable regulatory requirements. The incumbent serves as a key liaison between GCPM, GCO Regional Heads, regional organizations, Global Process Owners, Subject Matter Experts, and cross-functional partners to support process development, revision, adoption, and implementation. The role contributes to continuous improvement by translating process changes into practical business implications, consolidating regional feedback, escalating key concerns or recommendations, and assessing local or regional regulatory and operational impacts on global processes. In addition, the incumbent may act as Global Process Owner for assigned documents, lead review and approval workflows, contribute to process-related training strategy and materials, and mentor selected Associate Directors to support capability development and consistent process leadership.

Responsibilities:

• Drive the execution of global clinical process management activities within GCO, ensuring processes and standards are efficient, consistent, sustainable, and compliant with applicable regulatory requirements.
• Serve as the primary GCOE point of contact for one or more assigned GCO processes, including related SOPs, work instructions, and standards.
• Contribute to the development of GCO procedural content in collaboration with Global Process Owners and Subject Matter Experts and may act as Global Process Owner for assigned documents, including SOPs, work instructions, templates, and tools.
• Lead GCO process management initiatives, assessing the need to revise or create controlled documents and supporting continuous improvement, change management, and effective implementation.
• Lead document review and approval workflows to ensure timely progression, appropriate stakeholder engagement, and alignment with governance expectations.
• Act as advisor and reviewer for processes owned by other functions that impact GCO processes, standards, and ways of working.
• Establish and maintain effective partnerships with relevant GCO teams and cross-functional stakeholders, including GCP Compliance, Learning and Development, and other groups as required.
• Contribute to the development, strategy, and implementation of training materials related to GCO processes.
• Serve as the primary communication liaison between GCO Regional Heads, their organizations, and the GCPM team for processes under development or revision.
• Support effective adoption of new or revised processes by translating process changes into practical business implications for regional and local teams.
• Partner with Regional Head organizations to consolidate feedback, promote alignment, and support a coordinated regional perspective on process adoption.
• Escalate regional positioning, concerns, or recommendations to the Head of GCPM and the relevant GCPM Process Lead to enable appropriate follow-up, decision-making, and collaborative resolution.
• Relay key local and regional insights, including changes in local regulations or operational requirements, to assess and address potential impacts on global processes within GCPM scope.
• Mentor selected Associate Directors within GCPM, as assigned by the Head of GCPM, to support capability development, role effectiveness, and consistent process leadership.
  

Requirements:

• Fluent English (Oral; Written)
• Relevant bachelor’s degree minimum – preferred science/healthcare discipline
• Minimum of 8 years of experience in pharmaceutical and/or biotechnology sector
• Extensive knowledge of clinical operations process, ICH-GCP and compliance management; including application of clinical trial regulation/s
• Experience in clinical trial process design, harmonization/optimization and implementation.
• Experience working in matrix environment and in global teams
• Excellent interpersonal, problem-solving, negotiation and conflict resolution skills
• Excellent organizational skills and a pre-disposition to quality management and process improvement
• Effective communicator (oral and written)
• Strong presentation skills

Education Required:

• Bachelor’s degree required, master’s or other relevant post graduate qualification 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

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.