Associate Director / Director Global Clinical Process Management Lead

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

## Associate Director / Director Global Clinical Process Management LeadApply: Remote (US): Full time: Posted Today: R36864BeOne 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.**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:*** 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.**Supervisory Responsibilities:*** Matrix supervisory**Computer Skills:*** Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint, Project)**Other 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**Education Required:*** Bachelor’s degree required, master’s degree or other relevant post graduate qualification preferred.Global CompetenciesWhen 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 ClaritySalary Range: $143,300.00 - $193,300.00 annuallyBeOne 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.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 [e-mail].