Biosample Operations Lead

This role can be done in a hybrid model, 3 days from the office in Warsaw

Your Role:

Are you ready to take charge of end-to-end biosample operations in clinical study? In this role, you will lead execution of biosample operations activities from early feasibility and vendor set up through analysis and data delivery. You will act as the go-to expert for the clinical study team for any questions related to biosample operations. Your focus will be on ensuring every sample is collected, processed, and delivered for analysis to the highest quality and regulatory standards, all while keeping an eye on operational efficiency and patient comfort. You’ll lead central lab budget planning, oversee central lab setup, manage vendor performance, and drive execution of biosample operations activities in alignment with clinical study timelines. This position is based at our hub, working with global cross-functional teams, and requires up to 10% travel.

Who you are:

6+ years of clinical operations experience focused directly on biosample management within a pharmaceutical company or CRO.

Proven track record in managing central lab vendors and handling biosample logistics in Phase I–III clinical studies.

Deep, verifiable understanding of ICH-GCP, GLP, biobanking policies, and ethical standards.

Strong expertise in tracking timelines, budget forecasting, and executing proactive, risk-based mitigation strategies.

Excellent communication skills with an ability to influence cross-functional teams and lead audit readiness.

Bachelor’s or Master’s degree in Biology, Life Sciences, or Pharmaceuticals (PhD is a plus).

Professional fluency in written and spoken English.

Direct experience with companion diagnostics (CDx) development or biomarker/PK analysis requirements is of advantage.

YOUR MAIN BENEFITS:

Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card

Work-Life balance: Enjoy additional paid days off, flexible working hours.

Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities

Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection.

Information on how we process your personal data for recruitment purposes, you can find on the registration form in our Recruitment Portal.