Join us at AstraZeneca, where we are harnessing the power of cell therapy to revolutionize the treatment of life-threatening diseases. Within our Respiratory & Immunology (R&I) group, our exceptional team is creating a world-class organization dedicated to accelerating the delivery of transformative, next-generation cell therapies for patients with immune-mediated diseases. As a member of our R&I Biometrics and Statistical Innovation team, you will play a pivotal role in transitioning these groundbreaking therapies from the lab to patients.
As the Biometrics Team Leader for Cell Therapy Immunology, you will provide global strategic biometrics and statistical expertise to support the research, development, and commercialization of products targeting immunological diseases.
In this role, you will ensure comprehensive biometrics contributions across all phases of cell therapy development. You will have both line and matrix leadership responsibilities, contributing to the formation and growth of the Cell Therapy Immunology Biometrics team. This will involve close collaboration with the Head of Early Statistics and other key stakeholders across the company. Your leadership will be instrumental in driving the success of our cell therapy initiatives and ultimately improving patient outcomes.
What You'll Do:
- Lead the strategic and operational planning of the R&I/Cell therapy Biometrics contributions, to the Development Plans, Regulatory Strategy and Submissions, Health Technology Assessment and Commercial support of AZ products.
- Provide leadership for Biometrics staff world-wide so that all work is carried out with regards to AstraZeneca standards and external regulations
- Provides critical review and input on disease area and portfolio strategies, risk planning and mitigations.
- Ensure product/disease area/portfolio global strategies considering key regional requirements in close collaboration with regulatory, medical, and commercial from the regions.
- Leads discussions both internally and externally and develop strategies on novel development tools such as novel endpoints/biomarkers, novel study designs, digital tools.
- Provide leadership and direction to improvement projects/activities/initiatives and drive the implementation of best practice across the department.
- Together with your team lead colleagues secure biometrics delivery of the whole R&I portfolio.
- Represent AstraZeneca and Statistics to Health Authorities and Reimbursement/Payer organizations.
- Investigate and implement statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.
- Develop contacts with international opinion leaders, consultants, and collaborative groups.
- Effectively represent the Biometrics function in senior level interactions at internally governance technical review committees e.g. Development Review Committee (DRC/eDRC), Early Development Review Board, Global Medical Affairs (GMA) Review Committees
- Be aware of, and comply with, all appropriate AZ and R&D Cell Therapy Immunology procedures.
- Maintain good collaboration across the AZ internal Biometrics community, including colleagues in R&I, CVRM, V&I, Oncology and in CMO.
Essential for the role
- MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognized equivalent to stats MSc
- Track record of background in leading independently
- In depth knowledge of technical/regulatory requirements with experience in pharm/healthcare
- Exemplary technical skills
- Excellent communication skills and ability to build strong relationships
Desirable for the role
- Managerial experience
- Excellent collaboration required – needs the energy to work across global & functional boundaries both internally and externally
- Vision – keen awareness of R&D priorities in order to apply novel solutions to scientific problems
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
Date Posted
04-Oct-2024Closing Date
06-Oct-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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