Jobs at Crescent Biopharma, Inc.

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.

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 corporate development strategy for a clinical-stage oncology biopharma. Responsibilities include monitoring the solid-tumor landscape, maintaining portfolio matrices, identifying and evaluating licensing and collaboration opportunities, conducting competitive and clinical intelligence, performing gap analysis, and preparing recommendations for executives and the Board. The role partners across Research, Clinical Development, Business Development, and leadership to prioritize assets and support portfolio growth.

Own end-to-end clinical supply chain strategy across Phase 1–3 programs, including demand forecasting, supply planning, packaging, labeling, distribution, IRT/IWRS, and global regulatory compliance. Manage CDMOs, depots, logistics vendors, budgets, risks, and vendor performance across US, EU, and Greater China trials. Build supply chain processes and SOPs from the ground up, collaborate cross-functionally with CMC, Clinical Operations, Regulatory, and Quality, and mentor growing team members.

Lead and manage the bioanalytical function for preclinical and clinical programs, develop BA strategy, oversee CRO activities and audits, ensure GLP/GCP compliance, contribute to regulatory submissions, and manage budgeting and QA processes.

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.