Jobs 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.

Lead global regulatory CMC strategy and submissions (INDs, CTAs, BLAs, MAAs); manage regulatory interactions with authorities; advise TechOps/Quality on compliance; identify and mitigate regulatory risks; and manage junior staff and contractors.

Provide high-level administrative support to R&D and medical C-suite leaders: manage complex calendars, travel, meeting coordination, document preparation, confidential records, cross-functional liaison work, and operational support for clinical and regulatory workflows.

Support Clinical Study Lead and Clinical Operations to execute oncology clinical trials: CRO/vendor oversight, site support, eTMF and document control, study tracking, meeting materials, cross-functional coordination, training management, risk escalation, and inspection readiness.

Provide strategic and hands-on GMP QA leadership for biologics manufacturing across outsourced CDMOs, including batch review and release, tech transfer, PPQ, audits, issue/CAPA management, regulatory submission support, eQMS implementation, and mentoring QA staff to ensure clinical supply and commercial readiness.

Lead design, implementation, and oversight of Crescent's Quality Management System and GxP digital platforms. Ensure validation, data integrity, vendor qualification/oversight, inspection readiness, change control, metrics reporting, and continuous improvement while partnering cross-functionally and mentoring QA staff.

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 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.