• Provide scientific guidance to Rethymic Development and Manufacturing teams aligned with overall program goals • Review scientific rationale for regenerative medicine CMC and clinical • Review and edit technical development and scientific strategy documents for Rethymic • Review critical PAS submission documents for Rethymic, providing critical insight and alignment with rationale and regulatory expectations • Engage with CROs for in vivo rodent studies and model generation • Finalize ERA plan for nuvisertib: Confirm study scope, endpoints, and required test articles; align with Chemical, Manufacturing and Controls (CMC) timelines and supply • Vendor & budget leadership: Convert the current discussions and quotes into an executable statement of work (SOW) and detailed budget; secure start dates • Operational coordination: Orchestrate cross‑functional inputs (CMC, tox, program management), and track milestones through GDPM/Oncology forums • Ensure ERA outputs meet internal risk‑management documentation expectations and are ready for downstream use to support NDA filing with EMA for nuvisertib