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Global Clinical Programme Lead - Inflammatory Bowel Disease

Company: AstraZeneca PLC
Location: Durham
Posted on: May 6, 2021

Job Description:

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 Programme Lead, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives. The Biopharmaceuticals Research & Development, Late-stage Clinical Development, Respiratory & Immunology (R&I) function drives late-stage development of our innovative pipeline, including in inflammatory bowel diseases, transforming exciting science into valued new medicines and ensuring patients around the world can access them. The Global Clinical Programme Lead is responsible for managing global or regional therapeutic or research projects or acting as a specialist 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 specialist in own field. Responsibilities: * Defines strategies or leading AstraZeneca's response to complex technical issues for specific medical aspects in relation to current projects, new projects and broader therapeutic area * Provides expert advice in the therapeutic area, including in inflammatory bowel diseases, influencing programme development according to 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 higher-level documents * Supports the development of clinical documents in assigned project Essential for the role: * Physician with specialist training in Gastroenterology, Allergy/Immunology, or Internal Medicine OR a Clinical Scientist with a higher degree and significant clinical development experience in the above specialties * Minimum of 3 and ideally more than 5 years 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 cross functional collaboration, including leading cross functional study teams * General understanding of medical statistics, safety, regulatory requirements. Desirable * PhD or PharmD in scientific subject area * Extensive general medical knowledge * Experience in leading late phase clinical trials in inflammatory bowel diseases in Industry So, what's next? Are you already imagining yourself joining us? Good, because we can't wait to hear from you! Advertising opens on 28th April 2021 and we welcome with your application; CV and cover letter, no later than 28th May 2021 For more information please contact: andrew.joss@astrazeneca.com Additional information Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines. Covid-19 Resources More information about our sites: * Cambridge, UK * Gothenburg, Sweden * Gaithersburg, US Date Posted 28-Apr-2021 Closing Date 28-May-2021 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.

Keywords: AstraZeneca PLC, Durham , Global Clinical Programme Lead - Inflammatory Bowel Disease, Healthcare , Durham, North Carolina

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