Director, Biosampling Business Area Leader

Precision Medicine and Biosamples 

AstraZeneca's Precision Medicine and Biosamples (PMB) group is driven by patient need. Our ambition - to develop innovative, targeted medicines for every patient that needs them - and to match those treatments to patients most likely to benefit from them – is now a reality. Human Biological Samples (HBS) are fundamental to the discovery, development and implementation of new diagnostics and treatments. 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. 

Clinical Sampling is a key team within Precision Medicine and Biosamples providing 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’ll Do 

Director, Biosampling Business Area Lead, is a key leadership role within Precision Medicine and Biosamples. The role holder is a clinical operation orientated leader and line manager accountable for the Clinical Sampling strategy and HBS risks for their Therapy Area. They build and continuously develop a team of Clinical Sampling experts in a highly, matrix environment that develops and continuously maintains the highest clinical sampling and HBS expertise.  

The role holder will be aligned to one of the AZ Therapy Areas – Oncology, Cardiovascular, Renal, Metabolism, Respiratory, Inflammation, Vaccine, Immune Therapies and Rare Diseases. As the primary Clinical Sampling leader for their Therapy Area they are accountable for strategic planning of all HBS aspects of the Therapy Area deliveries. Leading coordination and optimisation of a wide range of scientific and Clinical Sampling strategies from key stakeholder including Patient Safety, Translational Medicine (TM), Bioanalysis and Biomarkers. They work across the entire Therapy Area clinical portfolio covering all clinical trial phases and sampling related activities and are responsible for disseminating the TA strategy within Precision Medicine and Biosamples. Supporting best clinical practise and HBS regulations, in line with functional objectives through active cross functional engagement and development opportunities. They lead risk management and mitigation in the TA clinical strategy and lead resolution, working as required with the Biosamples 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. 

The role holder demonstrates the appropriate leadership, direction and accountability for leading and managing direct reports or in matrix to ensure achievement of objectives, personal development, and ensuring the team is trained and equipped to achieve established goals and to meet the needs of AZs clinical portfolio. They are accountable for the recruitment, retention and talent management of their team. 

 

Typical Accountabilities 

• Understand the scientific and clinical strategy for a TA and lead the development of strategic 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 Clinical Sampling group or across Precision Medicine and Biosamples to ensure delivery of key targets.  
• Collaborate with R&D leaders on HBS data opportunities and prioritize to have maximum impact on AZ clinical programmes 
• Setting multiyear strategy for HBS 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 Procurement 
• Monitoring, reporting and maximizing HBS Data: agreeing performance metrics and ensuring delivery of the team 
• Ensuring capability best practice and ways of working (Automation) of HBS Data and ensuring teams are compliant to AZ Data guidelines and regulations 
   

Essential 

• 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  

Desirable 

• 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