Associate Director, Global Clinical Process Management Lead

at  BeiGene

BeiGene 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 will champion the investigation, development and implementation of process management activities for Global Clinical Operations; Working collaboratively with relevant GCO team members globally, to ensure BeiGene GCO standards and processes are efficient, optimized and maintained in compliance with ICH-GCP and regulatory requirements

Responsibilities:

• Execution of global clinical process management within GCO ensuring efficiency, consistency, sustainability and compliance with regulatory requirements across GCO processes and standards
• Primary GCOE point of contact for one or more GCO processes (SOPs/WIs) and related standards
• Content contributor, collaborates with GCO Global Process Owner (GPO) and Subject Matter Experts (SMEs), or may act as the GPO on technical writing of GCO procedural documents including SOPs, Work Instructions, Templates and Tools
• Leads GCO process management initiatives, in collaboration with GCPC assesses the need for revision and creation of controlled documents, supporting continuous improvement, change management and implementation
• Leads document review and approval workflow
• Advisor/Reviewer of processes owned by other function/s that impact GCO processes and related standards
• Establishes successful partnerships with relevant GCO and cross functional groups i.e., GCP Compliance, L&D and other stakeholders as required
• Contributes to the development and strategy of training materials related to processes

Requirements:
Education Required:
Bachelor’s degree required, Master’s or other relevant post graduate qualification preferred.

Other 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

Computer skills: Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint, Project) Other Qualifications: Six sigma certification and/or experience with process mapping desirable.
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget.
BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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

We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.

• Execution of global clinical process management within GCO ensuring efficiency, consistency, sustainability and compliance with regulatory requirements across GCO processes and standards
• Primary GCOE point of contact for one or more GCO processes (SOPs/WIs) and related standards
• Content contributor, collaborates with GCO Global Process Owner (GPO) and Subject Matter Experts (SMEs), or may act as the GPO on technical writing of GCO procedural documents including SOPs, Work Instructions, Templates and Tools
• Leads GCO process management initiatives, in collaboration with GCPC assesses the need for revision and creation of controlled documents, supporting continuous improvement, change management and implementation
• Leads document review and approval workflow
• Advisor/Reviewer of processes owned by other function/s that impact GCO processes and related standards
• Establishes successful partnerships with relevant GCO and cross functional groups i.e., GCP Compliance, L&D and other stakeholders as required
• Contributes to the development and strategy of training materials related to processe