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Human Biological Samples (HBS) are used in every clinical study performed by AZ and form the basis of safety, pharmacokinetic and efficacy endpoints that are used in regulatory files to achieve launch, and are essential for AZ's business success. As AZ's portfolio expands in volume and complexity, the dependence on effective HBS infrastructure and processes will also increase. Samples for exploratory research are also taken in AZ's clinical studies.
The Business Area leader Biosamples is a key leadership role within the Biosamples Department. The role holder is the owner for the clinical sampling strategy and HBS risks for a business area and for line management of a team.
As the Biosamples primary TA contact they are accountable for understanding HBS aspects of the translational (TM) and precision medicine (PM) strategies, disseminating the strategy within Biosamples and leading the development of timely and compliant HBS plans.
They track issues and risks in the PM, TM or clinical TA plans and lead resolution, working as required with the Alliance Leads to provide solutions, ensuring learning is identified to support continuous process improvement.
They are also accountable for ensuring that timely and accurate reports are produced for senior leaders across R&D.
Typical Accountabilities, what you will be doing:
You'll be responsible for the line management and development of a team of clinical sampling experts that provide HBS and sampling expertise to meet the needs of the R&D clinical portfolio. You will oversee the output and ensures delivery from your team and use of the defined RACI and operating model. You will also be accountable for the recruitment, retention and talent management of your team.
Understand the translational and precision medicine strategy for a TA and lead the development of Biosamples responses.
Maintain an oversight of clinical sampling issues impacting a clinical, translational or precision medicine TA unit and lead the resolution of escalated issues in a timely, accurate and compliant manner.
Ensure learning from issues are identified to enable continuous process improvement.
Provide expert guidance and advice to ensure clinical sampling activities are compliant with global regulations
Line management, development and maintenance of clinical sampling skills to meet the current and future needs of the portfolio. Accountable for recruitment, retention and talent management of a team
Recruitment to the Clinical Sampling group with recruitment strategies and on-boarding processes that access talent and maximise the rate at which they start contributing.
Efficient deployment of resource to clinical studies/programmes working with the Business Manager
Maintain an oversight of the laboratory components of clinical programs or studies to ensure they are accurate and fit for purpose.
An oversight of sampling risks to delivery of clinical programs to enable appropriate mitigation
Oversight of quality and compliance of clinical sampling contributions to ensure appropriate input to programs
Drive consistent implementation of globally agreed processes, templates and technologies in their own team and as process owner across the function
Lead functional productivity or process improvement initiatives, within the CS group or across Biosamples to ensure delivery of key targets.
Collaborate with R&D leaders on BioSample data opportunities and prioritize to have maximum impact on AZ clinical programmes
Setting multiyear strategy for BioSample Data and ensuring implementation, including capability sizing, skill profile, supplier model, technology platforms, R&D strategy alignment and partnership with other supply functions such as IT and Procurment
Monitoring, reporting and maximizing BioSample Data: agreeing performance metrics and ensuring delivery of the team
Ensuring capability best practice and ways of working (Automation) of BioSample Data and ensuring teams are compliant to AZ Data guidelines and regulations
Education, Qualifications, Skills & Experience:
Higher degree (or relevant experience) in relevant scientific area
Experience of the clinical development process
Strong ability to work collaboratively in a cross functional setting
Strong coaching skills
Well developed written and oral communication skills
Ability to influence strategically to obtain desired outcomes while maintaining effective, positive, organisational relationships
A clear demonstration of behaviours of; Truth seeking rather than success seeking; Problem solver; Ownership for issue resolution; Embracing of peer review
Fluent in English as the AstraZeneca working language
Operational deployment of clinical laboratory testing in clinical trials across both early and late development
Experience in more than one company
Experience of leading and managing a team
Process ownership and process optimisation
Prior experience in a similar role
UK (Melbourn Science Park)
Salary: Competitive + Excellent Benefits
Next steps, if the role looks suitable please apply!