Business (Therapy) Area Leader - Biosamples
- Experience Level
Do you have experience in clinical development along with strong leadership and collaboration skills? If you do this could be the next great step for your career!
At AstraZeneca be empowered to be innovative and creative where difference is valued. Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve
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 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 therapy area (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.
You will 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. The role holder oversees the output and ensures delivery from their team and use of the defined RACI and operating model, and is accountable for the recruitment, retention and talent management of their team.
Typical Accountabilities, what you will be doing:
- 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 Procurement
- 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 and 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
- 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
Location: Melbourn Science Park UK or Gothenburg Sweden or Warsaw Poland or South San Francisco US
Closing Date: 7th May 2021
Salary: Competitive + Excellent Benefits
Next steps, if the role looks suitable please apply!
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