Opportunity: Global Clinical Programme Lead
Location(s): Gaithersburg or Durham (US), Cambridge (UK), Warsaw (Poland)
Salary: Competitive, with excellent company benefits
Bold Disruptors. Push the boundaries of science Fearlessly break new ground
Work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm.
And in return… we’re looking for curious minds, comfortable taking smart risks and learning from failures!
Work with curious minds in an inclusive culture
Seamlessly come together in our inclusive environment. Here all doors are open, and every voice is heard. From working side-by-side with academia to innovating with biotech – we are forever expanding our horizons.
Why we love it
Thrive in an energising environment where challenging work goes hand in hand with development. With opportunities, recognition and forward-thinking minds, there’s no better place to unlock learning and build a long-term career.
What you’ll do
As a Global Clinical Program Lead for Tezepelumab Life Cycle Management, you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. The Biopharmaceuticals Research & Development, Late-stage Development, Respiratory & Immunology (R&I) function drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them. The role could be located in Gaithersburg, MD,Durham, NC, Gothenburg SWE or Cambridge UK
The Global Clinical Program Lead is responsible for managing global or regional therapeutic or research projects or acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials. You will ensure projects adhere to Good Clinical Practice and regulatory requirements. In this role you will be able to deputize for global clinical head (GCH) and independently lead development activities for an indication or subset of the clinical development plan. You will be responsible for overseeing development of the functional strategy or acting as a renowned expert in own field.
- Defines strategies or leads AstraZeneca’s response to complex technical issues for specific medical aspects in relation to current projects, new projects and broader therapeutic area strategy
- Provides expert advice in the therapeutic area, influencing the development according to the global business and Global Clinical Development plan
- Closely follows medical developments within assigned areas and disseminates new information within Clinical Development to transform trends and emerging data into new plans
- Liaises with the internal and external medical community to follow developments within areas of expertise
- Contributes to or manages the development of the senior management team in area of expertise
- Leads regulatory communication and preparation of high level submission documents
- Supports the development of clinical documents in assigned project
Essential for the role
Science or medical degree (e.g. MD, PhD, PharmD), with specialist training or significant experience in allergy/immunology/autoimmune diseases and extensive experience from clinical development in pharmaceutical industry or academia. Minimum of 5 in Industry, with experience in leading clinical trials to support approval (Phase 2-4).
- Experience in leading a clinical program to support an indication, including overall design, clinical development plan and Target Product Profile .
- Experience in writing clinical aspects of briefing documents for regulatory interactions and played a critical role in writing sections of a submission dossier.
- Previous experience in working cross functionally including leading cross functional study teams
- Good knowledge of biostatistics, global regulatory environment and pharmacovigilance
Desirable for the role
- PhD or PharmD in scientific discipline
- Extensive general medical knowledge
So, what’s next?
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!
Advertising opens on 11th May and we welcome with your application; CV and cover letter, no later than 25th May 2021
For more information please contact: firstname.lastname@example.org
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