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 fit to 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 solve 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 Director, Biosamples Clinical Sampling 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 lead 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 will 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.

Director, Biosamples Clinical Sampling, is a key leadership role within 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 \xe2\x80\x93 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), Precision Medicine (PM), 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 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 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, what you will be doing:

• Understand the scientific and clinical 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 Biosamples 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 Procurement
• Monitoring, reporting and maximizing BioSample Data: agreeing performance metrics and ensuring delivery of the team
• Ensuring capability standard methodology and ways of working (Automation) of BioSample Data and ensuring teams are compliant to AZ Data guidelines and regulations

Education, Qualifications, Skills & Experience:

Essential Minimum

• Higher degree (or proven 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

Desirables:

• 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

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 18-Jul-2023

Closing Date 08-Aug-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.

AstraZeneca