Biosampling Project leader, Biosamples

Location: Warsaw, Poland
Hybrid model of work: 3 days in office, 2 remote per week

Human Biological Samples (HBS) are fundamental to medical research in the discovery, development and implementation of new treatments and diagnostics. They are ethically sensitive materials and underpin the delivery of every clinical trial.

The Biosampling Project leader (BPL) is accountable for the oversight of the central laboratory and biobanking activities on the studies in their program. The Role holder is responsible for ensuring operational input into the clinical study protocol, clinical laboratory testing of human biological samples and the efficient operational deployment of such clinical laboratory testing (including biomarkers, central safety testing and clinical bioanalysis for pharmacokinetic assessment). The scope covered by the role holder covers all clinical trial activities and sampling related activities in the project regardless of phase and as such they may be deployed to any R&D or Affiliate projects.

Typical Accountabilities

• Accountable for sponsor oversight of the central laboratory activities within the clinical studies in the assigned programs using best practice project management and communication skills
• Accountable for overseeing the compliance of the clinical study sample lifecycle where responsibility is delegated to the Biosample project manager, Clinical Sample Scientist, study team and science functions
• Provide appropriate operational contribution to the inclusion of laboratory testing of human biological specimens into clinical programmes and trials
• Ensure all the laboratory components within planning operational delivery documents are accurate and fit for purpose.
• Ensuring strategy for the project sampling plan is deployed and lessons learnt within and across programs are communicated to the study level personnel
• Oversee delivery of laboratory services and data from external providers at a project and occasionally study level to understand and mitigate risks to delivery
• Act as the first point of escalation for biosampling issues to bring expertise to resolve problems
• Provide business oversight of external laboratory budgets
• Maintains an up to date knowledge of current sample management and analysis techniques and regulations
• Contribute to clinical laboratory training & education and to maintenance of relevant SOPs, guidelines, and template
• Accountable for the facilitation of compliant future use sampling requests within the project
• Accountable for Human Genetic Resources compliance within the studies in the assigned program
• Contribute to the development of new processes and deployment of automation technologies.
• Contribute to the validation and assessment of technologies that can transform end to end BioSample processes
• Preparation and manipulation of BioSample data (internal, external, structured, unstructured) in order to make business decisions.
• Developing, maintaining and applying ongoing knowledge and awareness in trends, best practice and innovation in BioSample data / technologies

Essential

• Degree (or relevant equivalent qualification) in relevant area, or equivalent industry experience.
• Proven experience in contributing to operational deployment of clinical laboratory testing
• Proven experience in oversight of external partners, especially clinical laboratory service providers
• Excellent analytical, written and oral communications skills
• High ethical standards, willingness to challenge inappropriate proposals/actions
• Strong collaborative skills
• Willingness to take decisions and find solutions
• Fluent in English as the AstraZeneca working language

A clear demonstration of behaviours of:

o Truth seeking rather than success seeking

o Agile responsiveness to scientific data

o Embracing of peer review

o Agnostic to internal-external sourcing

o Problem solver

o Leadership

Desirable

• Clinical Laboratory scientific experience
• Experience of management of complex projects

Date Posted

31-lip-2025

Closing Date

13-sie-2025

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.