Associate Director, Data Disclosure & Transparency

• Supervises BeOne’s Clinical Data Publication activities in accordance with BeiGene policy and international regulations.
• Monitors transparency compliance across BeOne’s portfolio of studies and may write, submit, and manage disclosure and transparency activities in accordance with BeOne policy and international regulations
• Supports the development and maintains strategies for improving departmental systems and processes and ensuring optimal team performance in meeting key transparency deliverables, including mentoring and training team members

Essential Functions of the job:

• Supervises the execution of clinical trial disclosure information to regulatory authorities and Clinical Data Publication submissions to EMA and Health Canada
• May write and submit registration and tabular results and lay summaries, perform document redactions, and facilitate data anonymization throughout the study lifecycle in accordance with BeiGene policy and international regulations
• Ensures up-to-date data disclosure tracking tools and dashboards maintained by team members in compliance with applicable registration and results posting and data sharing requirements
• Directs the development and implementation of special projects, processes, standards, and training material for Data Disclosure & Transparency activities
• Represents function at the highest degree with proactive interactions with colleagues
• Expert knowledge of clinical trial transparency regulations and keeps current with changes in local and international clinical trial transparency requirements
• Provides tactical guidance to department colleagues on global transparency requirements
• Serves as primary point of contact for escalation and resolution of clinical trial transparency issues
• Supervises transparency compliance monitoring, dashboard reporting
• Participates on project teams to provide guidance on public disclosure and data sharing processes and requirements, including regulatory requirements for content and format
• Manages resource planning and deployment to ensure appropriate study/program support and identifies future resourcing needs and communicates to functional leadership
• Sets employee goals and establishes expectations that contribute to department’s vision and long-term planning and manages the status of ongoing projects with direct reports
• Supervises and trains team members
• 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
• Supports vendor relationships including required resources, issue resolution and contract negotiation
• Achieves optimal team performance in meeting key clinical trial transparency deliverables

• Experience with ClinicalTrials.gov (PRS) required; experience with other data disclosure repositories preferred (e.g. CTIS, ChinaDrugTrials.org)
• Experience with Adobe redaction and supporting tools preferred
• Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Visio, and Outlook; Adobe Acrobat
• Experience with Adobe Illustrator and InDesign preferred

Education Required:

8+ years of relevant experience and a BA or BS or 6+ years with Master or above, * 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 and transparency processes required
• Excellent verbal and written skills
• Ability to translate complex information into understandable language for diverse stakeholders preferred
• Attention to detail, time management, and ability to balance multiple tasks to achieve goals and meet deadlines
• Strategic thinking, with a focus on process development, improvement and optimization
• Experience with unique problem-solving where issues are not clearly defined and sufficient information to describe problems may not be available