Senior Director, Head of Global Clinical Process Management

BeOne 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.

• Strategically lead all efforts related to ensuring clinical operations process excellence
• Conduct gap analyses; identify potential risks to clinical operations related to process and inspection readiness; operationalize mitigation strategies in collaboration with key stakeholders/leadership
• Strategically evaluate and implement solutions to address any operational geographic gaps related to ensuring clinical operations process team is set up for optimal execution
• Optimize current state clinical operations processes and maintain document lifecycle management and continuous process improvements
• Develop and communicate future state strategies to clinical operations leadership team
• Support organizational change management efforts for Clinical Operations
• Provide strategic expertise and facilitate leadership alignment of cross functional SOPs
• Effective partnership and collaboration with cross functional leaders/stakeholders (e.g. Clinical Development, Data Management, Quality, Regulatory) as it relates to planning, interdependencies, and risk mitigations for global processes.
• Partners with cross functional teams, Global Clinical Operations Global Process Owners to design and implement a clear, well-defined process with clear inputs, outputs, and roles & responsibilities – integrates people, process, and technology components of process design.
• Leads Global Clinical Operations process improvement teams/workstreams tasked with re-designing or improving processes including establishing timeline for process improvement projects.
• Develops process maps and other process documentation to facilitate the team’s analysis and optimization of processes.
• Assists Global Clinical Operations, Global Process Owner with change management and implementation of process improvements.
• Keep Global Clinical Development key stakeholders and other relevant functions informed of new processes or process updates requiring SOP updates owned by Global Clinical Operations function. Reviews SOPs and training documentation resulting from these new processes or process improvements.
• Chair Global Clinical Operations SOP Governance Board. Develop and maintain Governance charter, process.
• Monitor key metrics and partners with Global Clinical Operations, Global Process Owner to identify and address gaps/deficiencies.
• Works with CRO partners to ensure optimization of key process interfaces to ensure seamless integration of internal and external activities as required.
• Works with Global Process Owner to capture and communicate Lessons Learned.

• Develops direct and indirect reports to enhance the business across all areas.
• Leads and develops staff, including mentoring, coaching, and performance management.

• Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint and Project).

• Mid/large pharma experience (preferably clinical operations, process, quality, or compliance roles)
• ICH GCP subject matter expert
• Knowledgeable of regulatory requirements (e.g., FDA, MHRA/EMA)
• Experience working in a cross-functional, global environment
• Strong written and verbal communication skills
• Deep experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, project management)
• Strong leadership, collaboration, and influencing skills in a complex, matrix environment including team leadership or project management
• Experience in clinical trial process design, harmonization/optimization, and implementation
• Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvement.
• Six Sigma certification and/or experience with process mapping tools (e.g., Visio, Power Point) desirable.

Education Required:

Bachelor’s Degree with minimum of 12+ years of experience in pharmaceutical or biotechnology drug development; Master’s degree preferred.

Global Competencies

When 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 Clarity

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. 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 [email protected].