Advisor, Bio Sample Operations – DMPK

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $153k - $246.4k / year

⏰ Full Time

🟠 Senior

🔴 Lead

⚙️ Operations

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Eli Lilly and Company

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Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 Description

• 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

🎯 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 biomarker operations and clinical bio sample lifecycle management • Proven project management skills, with the ability to balance multiple complex priorities in a matrixed organization • Experience working cross-functionally and managing central and specialty laboratory vendors and other international partners • Strong knowledge of GCP principles, clinical research quality standards, global trials, and multi-country sample logistics • Experience with LIMS, bio sample or clinical trial management systems, sample tracking, reconciliation, and integration of laboratory and clinical data • Strong communication, organization, stakeholder management, and problem-solving skills • Ability to travel approximately 10%-20%, including visits to CROs and external partners as needed

🏖️ Benefits

• Company bonus depending, in part, on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical benefits • Dental benefits • Vision benefits • Prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities

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