Advisor, Bio Sample Operations - DMPK

100 Eli Lilly and Company; United States; Remote; USD 153,000 - 268,000; Full time

Job summary

Eli Lilly and Company is seeking an Advisor, Bio Sample Operations to lead the planning and delivery of clinical bio sample activities across multiple programs. You will oversee end-to-end sample lifecycle and coordinate with Clinical Operations, QA, Regulatory, and external vendors to ensure timely delivery with quality standards.

Responsibilities include lifecycle management, cross-functional coordination, and risk mitigation across global sites and partners. Travel up to 20% may be required.

Qualifications

• Experience in clinical bio sample lifecycle management.
• Strong knowledge of GCP principles and global trials.
• Experience working with central and specialty labs/vendors.

Responsibilities

• Lead bio sample operations across clinical studies from start-up to final disposition.
• Translate protocol and lab requirements into study-specific bio sample strategies and plans.
• Oversee end-to-end bio sample lifecycle: collection, processing, labeling, shipment, storage, analysis, reconciliation, retention and disposition.
• Coordinate cross-functional teams and external partners to deliver bio sample activities on time and within budget.
• Manage central and specialty laboratories, biorepositories, couriers, CROs and vendors, including contracts and KPIs.
• Maintain sample traceability, chain of custody, inventory accuracy, and system alignment.
• Identify, resolve and elevate operational and quality issues, including CAPAs and audit findings.

Skills

Bio sample operations

Project management

Cross-functional collaboration

Communication

Problem-solving

Education

Bachelor's degree in life sciences or related

Tools

LIMS

Sample tracking systems

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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 elevate 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 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.

Additional Preferences

• Intrinsically curious and deeply passionate about the work we do.
• Embrace ambiguity and push for new practices and technologies.
• Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn’t clear.
• Leverage technical depth and a growth mindset to make impact; imagine what’s possible and pursue it with intention and energy.
• Demonstrate curiosity and drive self-identified innovation, especially in the exploration of artificial intelligence and digital.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $153,000 - $268,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly