Remote Global Clinical Process Lead - Associate Director

BeiGene, Ltd.; Northern (KY); Hybrid; USD 143,000 - 193,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Time Off

Wellness Program

Employee Stock Purchase Plan

Job summary

BeOne Medicines Ltd. is seeking an Associate Director / Director Global Clinical Process Management Lead to drive standardized, compliant workflows across Global Clinical Operations.

The role emphasizes collaboration with GCO stakeholders, regulatory alignment, and continuous process improvement in a remote US setting. Ideal candidates bring at least 8 years in pharma/biotech, deep knowledge of ICH-GCP, and experience in process design and harmonization.

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

Responsibilities

• Execute global clinical process management activities to promote efficiency, consistency, sustainability and regulatory compliance across GCO processes.
• Serve as the primary GCOE point of contact for SOPs, Work Instructions, and related standards.
• Contribute to content development and collaborate with GCO Global Process Owners and SMEs, or act as Global Process Owner as appropriate, in drafting procedural documents.
• Lead GCO process management initiatives in collaboration with GCPC, including document revisions and implementation activities.
• Identify and advance innovative ideas that improve GCO processes with stakeholder alignment from concept to implementation.
• Lead document review and approval workflows.
• Advise on processes owned by other functions that impact GCO processes.
• Establish and maintain partnerships with GCO and cross-functional groups.
• Contribute to the development and direction of training materials related to GCO processes.

Skills

Fluent English

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Microsoft Outlook

Microsoft Project

Education

Bachelor’s degree in science/healthcare

Tools

Microsoft Project

Job description

BeOne Medicines Ltd. is seeking an Associate Director / Director Global Clinical Process Management Lead to drive standardized, compliant workflows across Global Clinical Operations.

The role emphasizes collaboration with GCO stakeholders, regulatory alignment, and continuous process improvement in a remote US setting. Ideal candidates bring at least 8 years in pharma/biotech, deep knowledge of ICH-GCP, and experience in process design and harmonization.