Associate Director, Clinical Data Transparency and Disclosure

Key Responsibilities

• Define and lead the global clinical data transparency strategy, ensuring alignment with corporate objectives, regulatory requirements, and patient advocacy initiatives.
• Act as Clients subject matter expert for ClinicalTrials.gov, EU CTR (CTIS), EudraCT, EMA Policy 0070, Health Canada PRCI, and other global registry requirements.
• Anticipate and assess evolving disclosure and transparency regulations worldwide, driving proactive policy and process updates.
• Represent Apellis in external industry forums, working groups, and regulatory discussions related to data transparency.
• Establish and maintain Apellis disclosure governance framework, including SOPs, quality standards, and audit readiness practices.
• Oversee development of redaction and anonymization strategies for clinical study documents and patient-level data, ensuring compliance with global privacy laws (e.g., GDPR, HIPPA).
• Provide strategic guidance on plain language summaries and patient-facing transparency deliverables.
• Direct and oversee the registration, results posting, and updates in ClinicalTrials.gov, EU CTR, EudraCT, and other global registries.
• Ensure timely, accurate, and high-quality disclosure deliverables across all global development programs.
• Manage relationships with external vendors, technology platforms, and disclosure service providers.
• Partner with stakeholder functions (e.g., Clinical Development, Clinical Operations, Medical Writing, Biostatistics, Data Management, Pharmacovigilance, Legal, Corp Comms, Investor Relations, and Regulatory Affairs) to ensure consistency and accuracy of disclosed information.
• Provide training and strategic guidance to relevant teams on global transparency requirements and best practices.
• Foster a culture of accountability, quality, and innovation within the team and across RDMA.