AtaiBeckley

• Establish and oversee the sponsor's participant support framework across clinical development programmes • Define the safety-focused support model, develop scalable training curricula for dosing session monitors • Establish fidelity monitoring systems to ensure consistent, high-quality participant care and ensure regulatory compliance • Serve as the internal subject-matter expert on participant support, providing scientific and operational leadership • Collaborate with Medical, Clinical Operations, Regulatory Affairs, Quality Assurance, and Commercial functions • Define and implement the participant support model, including terminology, competency frameworks, and operational workflows • Develop participant-facing materials and facilitator resources including pre-dose education content and post-dose safety information • Author and maintain participant support manuals and ensure version control • Design, build, and deliver a scalable facilitator training curriculum covering patient assessment, monitoring, crisis management, and research ethics • Implement qualification criteria and review processes to document monitor readiness and maintain training records • Establish adherence and fidelity metrics for evaluating facilitator performance against the participant support manual • Oversee systematic review of dosing session recordings and provide timely feedback to sites and dosing monitors • Engage with investigators, site staff, and external researchers to incorporate emerging evidence and ensure the participant support model reflects current understanding