Teams at Crescent Biopharma, Inc.

Lead clinical data management across study lifecycle, manage CRO deliverables, design and validate eCRFs, oversee data cleaning and transfers, ensure SDTM-compliant databases and quality data for study decisions and publications.

Provide executive leadership for biostatistics across the oncology pipeline, focusing on trial design, statistical strategy from IND through BLA, regulatory interactions, vendor/CRO oversight, team building, SOPs/governance, and CDISC-compliant data standards to support registrational programs.

Lead and build the pharmacovigilance and patient safety function for oncology programs. Oversee safety surveillance, signal detection, risk-benefit assessments, regulatory interactions (FDA, EMA, NMPA), safety document preparation (DSURs, safety reports), vendor management, PV budgeting, and cross-functional integration to ensure global regulatory compliance and inspection readiness.