[Hiring] Associate Director / Director Global Clinical Process Management Lead @BeiGene

Role Description

The Global Clinical Process Management Lead is responsible for leading and supporting global clinical process management activities within Global Clinical Operations. 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.

• Execute 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.

Qualifications

• 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

Requirements

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

Benefits

• Medical, Dental, Vision
• 401(k), FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness programs
• Annual bonus plan for Non-Commercial roles
• Incentive compensation plan for Commercial roles
• Discretionary equity awards
• Employee Stock Purchase Plan

Company Description

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. The recruiter can share more about the specific salary range for a preferred location during the hiring process.

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 [email protected].