Jobs at Crescent Biopharma, Inc.

Lead QC operations for biologics across CDMOs and CTLs, managing stability, specifications, reference standards, method transfers, validation, data integrity, regulatory Module 3 support, OOS/OOT/CAPA oversight, and mentoring QC staff to ensure GMP and ICH compliance throughout product lifecycle.

Lead cross-functional CMC project management for clinical-stage oncology programs: create and maintain integrated plans, manage timelines, risks, vendors (CDMOs/CROs), support CMC regulatory submissions, track budgets and resources, and implement process improvements to ensure delivery of CMC milestones.

Lead high-volume contract lifecycle for biotech agreements (CDAs, MSAs, SOWs, CTAs, vendor/supply and consulting agreements), draft/redline, manage negotiations, maintain CLM (LinkSquares), enforce governance, support audits/diligence, mitigate legal/IP/privacy/regulatory risks, and improve contract processes across cross-functional teams.

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.