Director, Digital Clinical Operations Study Head

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 Director of Digital Clinical Operations Study Head is a member of the Digital GCO Leadership Team, responsible for leading a team, setting and implementing the GCO technology strategy with the goal to increase Global Clinical Operations’ Study related productivity, reduce rising costs of clinical trials, and reduce clinical trial inefficiencies. This will be achieved by:

• Owning and implementing Study specific strategies, processes and systems that emphasize productivity and high data quality standards, to support GCO’s vision of being a world-class clinical operation organization. Study specific processes include, but are not limited to Study Planning, Study Setup & Startup, Study Management including Protocol Amendments, Protocol Deviations, ICF Mgmt., Milestones Mgmt., Risks & Issue Mgmt. etc.
• Maintaining and enhancing existing clinical systems used by the GCO teams in Planning, Start-up, Managing and Closing clinical trials, and ensuring data are accurate, complete, and contemporaneous.
• Identifying, developing, and implementing innovative computerized systems strategies, business case, respective processes, change management including training and user adoption that support the Study specific planning and conduct of agile, high-quality, and efficient clinical operations. Experience with AI/ML solution implementation in Clinical Operations will be a plus
• Working with the Development & IT teams to identify, select, configure and implement vendor products
• Working with the Development & IT teams to collate user stories for functional requirements, participate in sprint planning, sprint testing, SDLC testing including UAT
• Focusing on technological solutions that will improve clinical trial experience of GCO users, quality, and speed of data collection. This may include, and is not limited CTMS, Study Startup, Study Feasibility Clinical Operations reporting & dashboards

The incumbent will work directly with other members of the GCO, Development and IT organizations and be accountable to create policies and procedures where needed, introducing, and implementing novel technology solutions, processes and Roles & Responsibilities.

Essential Functions of the job:  

Leadership and Vision

• Analyze technology and industry trends to identify specific opportunities that ensure BeiGene clinical trials and operations are conducted with fit-for-purpose, cost-effective and innovative computerized systems that are cohesive, efficient, reliable, and compliant with all applicable regulatory expectations
• Create the Study specific GCO technology strategy and roadmap and manage its implementation end-to-end, to increase Global Clinical Operations’ productivity, reduce rising costs of clinical trials, and reduce clinical trial inefficiencies
• Build and lead a proficient team that will work with users to understand their requirements and processes, identify automation opportunities, collaborate with vendors to create the necessary fit-for-purpose throughout their respective lifecycles
• Monitor, evaluate, and optimize the performance and quality of the technology solutions, as well as troubleshoot and resolve any issues that may arise
• Provide business and technical knowledge, and leadership behavior coaching to Clinical Operations Management Systems & Innovation and cross-functional team members
• Promote a culture that exemplifies agility, compliance, process-orientation, data-driven decision-making, and thoughtful use of technology and innovation
• Partner with internal BeiGene departments, including Development Data Science, QA and IT, to develop strategic goals, standards, policies, and procedures associated with computerized systems, including lifecycle management for existing systems, and the exploration, assessment, and implementation of innovative new systems
• Drive development and execution of Clinical Operations Management Systems & Innovation Team staffing strategy and plans
• Plan, monitor and adjust Clinical Operations Management Systems & Innovation Team workforce, to meet dynamic needs of study teams

Operational Efficiency and Productivity

• Provide operational expertise and identify, target, and secure new technological solutions that will increase productivity and efficiencies of the GCO organization and that of clinical trials
• Identify necessary skills to build within GCO and responsible technologies to implement Study specific digital solutions
• Oversee the development of clinical trial management system requirements and standards in alignment with stakeholders (Clinical Operations, Data Management, Supply Chain, etc.)
• Identify pain points and manual workflows, and develop technological solutions that will improve these challenges
• Act as highest escalation point on Study specific clinical trial systems for critical issues and ensure vendors provides timely and accurate resolution
• Ensure that the Clinical Operations Management Systems & Innovation Team coordinates acceptance testing (UAT), manages creation of test plan, as well as develops test scripts. (with assistance from IT or Development functions, as appropriate)
• Ensure development of clinical trial tools & systems training materials and delivering effective training to internal and external system users
• Focus on Study user expectation and satisfaction, and decreasing user burden. Proactively ensure system usability remains a high priority, and/or ensure users have the appropriate support structure and user community (training, user group etc.)

Compliance and Continuous Improvements

• Own and drive execution of the clinical trial management systems & innovation end-to-end process continuous improvement roadmap, and engage cross-functional teams with best practices and trend insights
• Participate in the development of global policies, Standard Operation Procedures (SOP), other controlled documents, and the end-to-end system processes
• Ensure that systems and documentation are compliant with all relevant Regulatory requirements, including 21 CFR Part 11, ICH E6 (R2) as well as in accordance BeiGene SOPs and processes
• Lead and support continuous improvement of system projects impacting GCO
• With support from QA, ensure qualification of vendors, support audit activities, and actively monitor vendor performance trends

Supervisory Responsibilities:  

• Build & Lead global Digital Study Clinical Operations team of business analyst(s) / Process analyst(s) / Data analyst(s)
• Provide functional and administrative managerial responsibilities to global direct reports
• Act as mentor to direct reports and their associates

Computer Skills: 

• Breadth of experience in clinical operations’ strategy, clinical system strategy, business case, roadmaps & delivery, transformation of systems and their respective processes, and new technology solutions to create unique and differentiated clinical operations’ value and business outcomes for Study Specific digital solutions
• Deep knowledge of clinical management systems and associated reporting and visualization tools used in Clinical Operations
• Proven project management, and/or IT project leadership skills aligning technology initiatives with organizational goals

Qualifications:    

• Bachelor’s or Master’s degree Computer Science, Business Administration, Operations Management
• 10+ years’ experience in drug development, managing clinical trial systems or relevant concentration
• 5+ years in leadership roles as leader in multicultural & international (global) environment a plus
• Must have good enterprise strategic thinking and analytical skills, with proven ability to translate GCO strategy into actions and goal achievement to serve GCO and Development
• Has a diverse background working with Sponsors, CROs, and Clinical sites; utilize past experiences and knowledge to work in an ambitious and fast-paced global company with a focus on optimizing current practices in Clinical Research
• Exhibits an agile mindset, strong cross-cultural awareness, and excellent communication skills
• Conceptual, analytical, and strategic thinking

Travel:  As needed

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

BeiGene 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 BeiGene 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 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.