Director, Data Disclosure & Transparency

General Description:

• Oversees BeiGene's Clinical Trial Disclosure and Data Transparency activities in accordance with BeiGene policy and international regulations

• Develops and maintains strategies for improving Departmental processes and assessing team performance to achieve optimal team performance in meeting key clinical trial transparency deliverables.

• Oversees data disclosure and transparency communication and outreach plans, external transparency landscape for maintaining BeiGene transparency excellence, and key performance indicators (KPI) demonstrating adherence to BeiGene policy and international regulations.

Essential Functions of the job:

• Oversees BeiGene's Clinical Trial Disclosure and Data Sharing of information to regulatory authorities and the public

• Drives development and implementation of processes, standards, and training material for Data Disclosure & Transparency activities, including development and maintenance of BeiGene Data Sharing Principles and Policy

• Generation and execution of strategic communication plans and channels for sharing of data.

• Provides strategic guidance to project teams and executive leadership on global transparency requirements

• Expert knowledge of clinical trial transparency regulations and keeps current with changes in local and international clinical trial transparency requirements

• Establishes processes and process updates across functions full suite of SOPs, Work Instructions, and Guidances for generation of Data Disclosure and Transparency deliverables

• Leads strategic processes and provides strategic value to the overall positioning of the department with BeiGene

• Leads and promotes initiatives in moving the company forward with the implementation of transparency activities

• Provides Assessment of BeiGene's performance in any external communications, trackers, and rankings related to Disclosure, Transparency and Data Sharing

• Represents BeiGene externally on all transparency matters

• Effectively describes complex issues and recommend a resolution or workaround to senior and executive management with appropriate consideration of possible impacts

• Oversees the collaboration with other functional areas and contributes to the creation of clinical trial transparency program level plans; identifies and allocates internal and external resources

• Analyzes trends and evaluates the impact of changes in clinical trial transparency requirements; communicates changes to appropriate areas and implements required changes to ensure compliance with required standards

Supervisory Responsibilities:

• Oversees resource planning and deployment to ensure appropriate study/program support and identifies future resourcing needs and communicates to functional leadership

• Sets functional goals which contribute to department vision and long-term planning

• Task management and performance management of direct reports, including but not limited to: performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, and regular meetings

• Identifies future resourcing needs and implements appropriately

• Manages vendor relationships including required resources, issue resolution and contract negotiation

• Develops and maintains strategies for improving departmental processes and assessing team performance to achieve optimal team performance in meeting key clinical trial transparency deliverables

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.

Computer Skills:

• Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is preferred

• Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Visio, and Outlook; Adobe Acrobat

• Knowledge in data disclosure repositories (eg TrialScope/DISCLOSE, EUDRACT, PRS, China Register) is required

Other Qualifications:

• Preferably 8 or more years of direct experience in Data Disclosure & Transparency

• Management experience required

• Core understanding and familiarity with Clinical Development, Clinical Trial conduct, Regulatory Submission process, and Data Disclosure/Transparency processes required. Excellent verbal and written skills

• Attention to detail, time management, and ability to balance multiple tasks to achieve goals and to meet deadlines

• Strategic thinking, with a focus on process development, improvement and optimization.

• Experience with unique problem-solving where issues are not defined clearly and sufficient information to describe problems may not be available

Travel:

5% travel may be required

Education Required:

10+ years of relevant experience and a BA or BS or 7+years with Master or above

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.