Director, Global Clinical Process Management Lead

BeiGene, Ltd.; Basel; On-site; AUD 180,000 - 240,000; Full time

Benefits offered by this job

Bonus scheme

Shares grant

Learning & development opportunities

Benefits program

Collaborative team

Job summary

BeOne is seeking a Global Clinical Process Management Lead to oversee global process standards within Global Clinical Operations. You will drive efficiency, consistency, and compliance across GCO processes and collaborate with stakeholders to implement changes from concept through implementation.

The role requires extensive experience in pharmaceutical or biotech clinical operations, deep knowledge of ICH-GCP, and proven ability to lead enterprise-wide improvement initiatives in a matrix

Qualifications

• Bachelor’s degree or higher in a science, health care, or related field.
• Typically 12+ years of progressive experience in pharma/biotech/clinical research.
• Proven experience leading complex global or regional clinical operations programs.
• Expert knowledge of ICH-GCP, trial regulations, inspections, and compliance.
• Experience in end-to-end process design, governance, harmonization, and lifecycle management.

Responsibilities

• Provide strategic support for global clinical process management across GCO to promote efficiency, consistency, sustainability, and regulatory compliance.
• Serve as the primary GCOE contact for one or more GCO processes, including SOPs and Work Instructions.
• Collaborate on content development and act as Global Process Owner as appropriate, drafting procedural documents and templates.
• Lead GCO process management initiatives with GCPC, supporting change management and implementation.
• Identify and advance innovative ideas to improve GCO processes with stakeholder alignment and follow-through.
• Lead document review and approval workflows.
• Advise on processes owned by other functions that impact GCO processes and standards.
• Establish and maintain partnerships with GCO and cross-functional groups (GCP Compliance, L&D, etc.).
• Contribute to training materials and strategic direction for GCO processes.

Skills

Leadership

Strategic thinking

Regulatory knowledge

Stakeholder management

Change management

Communication

Education

Bachelor’s degree

Master’s degree or higher

Job description

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 visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).

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.

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

• 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.

Global Competencies

• 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

Data Privacy

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.

China Mainland Job Posting

At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit