Job Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central fito our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Biosamples

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 and are critical to to AZs Bold Ambition to launch 20 new drugs by 2030.

Biosamples provides expertise on Human Biological Samples for all of AZ. We lead the sampling, analysis and logistics on every clinical program, the registration and storage of samples in the biobanks to support future science and the HBS compliance and governance to make sure that every human sample is treated in the right way. Together, through our operational and scientific expertise, we ensure quality samples, whether collected or purchased, are managed effectively and compliantly across their life cycle. Securing access to the right patients, the right assays and the right data and ensuring clinical trial compliance with GCP and HBS regulations.

What You\xe2\x80\x99ll Do

The Biosampling Project leader (BPL) is a clinical operations orientated leader accountable for the oversight of all HBS or Biospecimens in their projects or programs. BPLs are expected to handle a broad portfolio of projects and could work in any of the AZ Therapy Areas \xe2\x80\x93 Oncology, Cardiovascular, Renal, Metabolism, Respiratory, Inflammation, Vaccine, Immune Therapies and Rare Diseases. The BPL is accountable for strategic planning and oversight of all central HBS related activities from initial study design through to long term storage post study closure. The BPL drives consistency, quality and compliance across their programs and they are the catalyst for efficient operational deployment of clinical sampling and laboratory testing (including biomarkers, central safety testing, diagnostics and clinical bioanalysis for pharmacokinetic assessment). BPLs work across the entire AZ clinical portfolio covering all clinical trial phases and sampling related activities in R&D and Affiliate projects.

In the role as BPL you are expected to be able to work independently and be comfortable to prioritize the work for yourself to meet business objectives. BPLs are also part of improvement initiatives and you may contribute to functional and cross-functional initiatives as a Subject Matter Expert. You will work closely with our external lab partner to ensure timely delivery of relevant lab services and data and provide mentoring and support to colleagues at all levels of experience.

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 Biosampling 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 HBS, sample and lab 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
• 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 Biosamples processes
• Preparation and manipulation of Biosamples 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 Biosamples data / technologies

Essential

• Degree (or relevant equivalent qualification) in relevant area, or equivalent industry experience.
• Validated experience in contributing to operational deployment of clinical laboratory testing
• Validated 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:

• Truth seeking rather than success seeking
• Agile responsiveness to scientific data
• Embracing of peer review
• Agnostic to internal-external sourcing
• Problem solver
• Leadership

Desirables:

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

Great People want to Work with us! Find out why:

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

Date Posted 10-Jul-2023

Closing Date 31-Jul-2023

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.

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