Senior Manager / Associate Director, Clinical Sample Operations

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X. The Senior Manager / Associate Director, Clinical Sample Operations will lead the strategic operational planning, logistical execution, and oversight of biosample management across Crescent Biopharma’s global clinical trial portfolio. This role partners across Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, and Non-Clinical, and with external laboratory partners, to ensure clinical trial specimens—including biomarker, pharmacokinetic/pharmacodynamic, genomic, and other specialty samples—are collected, processed, tracked, shipped, stored, and analyzed in accordance with protocols, timelines, quality standards, and regulatory requirements. The ideal candidate combines strong program and project management capabilities, deep laboratory vendor-management expertise, and a meticulous understanding of the clinical sample lifecycle. The successful candidate will be a hands-on, collaborative leader who anticipates operational risks and develops practical solutions in a fast-paced biotechnology environment. Responsibilities Strategic Operations & Trial Lifecycle Support Sample strategy execution: Partner with Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, and Non-Clinical to translate scientific and development objectives into executable study-level sample management plans. Protocol and informed consent input: Collaborate with Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, Non-Clinical, and Clinical Operations to review clinical protocols, Investigator’s Brochures, informed consent forms, and related study documents and confirm that biological sample collection, processing, testing, storage, future-use, and destruction requirements are scientifically aligned, operationally feasible, and clearly defined. Laboratory manual oversight: Lead the authoring, cross-functional review, approval, and maintenance of study-specific laboratory manuals, sample collection instructions, and associated site materials. Collection kit readiness: Oversee design, production, distribution, inventory, and replenishment of sample collection kits for global investigative sites. Study execution: Represent Clinical Sample Operations on cross-functional study teams comprising Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, Non-Clinical, and other relevant functions; proactively identify risks and implement mitigation and escalation plans to protect sample quality and study timelines. Sample Logistics, Tracking & Data Integrity Chain of custody: Maintain oversight of the complete end-to-end lifecycle and chain of custody of clinical samples from site collection through transport, receipt, processing, testing, transfer, long-term biorepository storage, return, or final destruction. Global logistics: Coordinate shipment strategies and resolve time-sensitive issues related to couriers, customs, import/export requirements, temperature excursions, sample integrity, and site compliance. System implementation: Lead the development, implementation, validation support, and optimization of sample tracking systems and laboratory information management systems across clinical studies. Data reconciliation: Oversee routine cleaning and reconciliation of …

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