Senior Bio Sample Operations Leader

Lilly

Indianapolis (IN)

On-site

USD 153,000 - 268,000

Full time

8 days ago

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Benefits offered by this job

401(k) plan
Pension
Vacation benefits
Medical/dental/vision
Flexible benefits
Life insurance
Employee wellbeing programs

Job summary

Centessa Pharmaceuticals, a world-class clinical-stage company, seeks an Advisor, Bio Sample Operations to lead planning and operational delivery of clinical bio sample activities across programs. You will partner with Clinical Operations, Bioanalytical Sciences, Quality, Regulatory and external vendors to align strategy, logistics and lifecycle management.

In this globally distributed role, you will ensure on-time, compliant delivery, manage vendors, and drive process improvements while

Qualifications

  • 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 ability to balance multiple priorities in a matrixed organization.
  • Experience working cross-functional and managing central and specialty laboratory vendors and 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 and data integration.
  • Strong communication, organization, stakeholder management, and problem-solving skills.
  • Ability to travel approximately 10%-20%.

Responsibilities

  • Lead bio sample operations across clinical studies from start-up through database lock and final disposition.
  • Translate protocol and laboratory requirements into study-specific bio sample strategies and plans.
  • Oversee end-to-end bio sample lifecycle: collection, processing, labeling, shipment, storage, analysis, reconciliation, retention, disposition.
  • Coordinate cross-functional teams and external partners to deliver timelines, budget, and quality standards.
  • Manage central and specialty laboratories, biorepositories, couriers, CROs, and vendors, including contracts, deliverables and SLAs.
  • Maintain sample traceability, chain of custody, inventory accuracy, and alignment across systems.
  • Identify, resolve and elevate operational and quality issues including shipment problems and deviations.
  • Ensure compliance with protocols, GCP, SOPs and regulatory requirements, while improving processes.

Skills

Project management
Cross-functional collaboration
GCP knowledge
Communication
Problem solving
Stakeholder management
Travel willingness

Education

Bachelor's degree in life sciences/biotech/healthcare

Tools

LIMS
CTMS

Job description

Centessa Pharmaceuticals, a world-class clinical-stage company, seeks an Advisor, Bio Sample Operations to lead planning and operational delivery of clinical bio sample activities across programs. You will partner with Clinical Operations, Bioanalytical Sciences, Quality, Regulatory and external vendors to align strategy, logistics and lifecycle management.

In this globally distributed role, you will ensure on-time, compliant delivery, manage vendors, and drive process improvements while

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