Teams at Crescent Biopharma, Inc.

Lead IT operations, governance, and vendor relationships to execute the technology roadmap. Oversee infrastructure, cybersecurity, collaboration tools, business and GxP systems, project portfolios, compliance (NIST CSF, audits, validation), and IT policies. Partner with cross-functional leaders to ensure audit-ready processes and deliverables supporting clinical development and company growth.

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.