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Organization and Position Overview
Centessa Pharmaceuticals , a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.
As Advisor, Bio Sample Operations (equivalent to Senior Manager), you will lead the planning and operational delivery of clinical bio sample activities across multiple clinical programs. You will provide end-to-end oversight of bio samples supporting safety testing, pharmacokinetic analysis and biomarker assessments, ensuring activities are delivered on time and in accordance with study protocols, internal SOPs, quality standards, and applicable regulations.
Working in a cross-functional and global environment, you will partner with Clinical Operations, Bioanalytical Sciences, Quality, Regulatory and external vendors to align bio sample strategy, laboratory operations, sample logistics and lifecycle management. The role drives consistent execution across studies, countries, clinical sites, laboratories, biorepositories and other external partners while proactively managing operational risks and improving processes.
Responsibilities
• Lead bio sample operations across clinical studies, from start-up through database lock, closeout and final sample disposition.
• Translate protocol and laboratory requirements into study-specific bio sample strategies, timelines, workflows, manuals, collection materials and operational plans.
• Oversee the end-to-end bio sample lifecycle, including collection, processing, labeling, shipment, receipt, storage, analysis, reconciliation, retention, and disposition.
• Coordinate cross-functional teams and external partners to deliver bio sample activities on time, within budget and to required quality standards.
• Manage central and specialty laboratories, biorepositories, couriers, CROs, and other vendors, including contracts, deliverables, performance, KPIs, and SLAs.
• Maintain sample traceability, chain of custody, inventory accuracy, and alignment across clinical, laboratory and sample-management systems.
• Identify, resolve and escalate operational and quality issues, including shipment problems, missing samples, discrepancies, deviations, CAPAs, and audit or inspection findings.
• Ensure compliance with protocols, GCP regulations, internal SOPs, quality standards, and regulatory requirements, while improving processes through standardized tools, governance, metrics, and lessons learned.
Basic Requirements
• Bachelor's degree in life sciences, biotechnology, pharmacy, healthcare, clinical research or related discipline.
• 8+ years of relevant experience in pharmaceutical, biotechnology, CRO or clinical research environments.
• Experience in clinical trial operations, biospecimen management, laboratory or…