Global Clinical Head - GI Cancer and GI Cancer Strategy

AstraZeneca - Gaithersburg, MD - ASTRAZENECA At AstraZeneca, we win through the science, it's at the heart of our every success. Every decision is rooted in the limitless possibilities of what science can do. We focus our science in the areas of Oncology, Respiratory, CVRM and INA. We push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do. It gives us a reason to come to work every day. It reminds us why we exist as a company. It helps us deliver benefits to patients and create value for shareholders. It also sets the context for our employees' activities and the roles of our teams, partners and other collaborators. AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. ONCOLOGY At AstraZeneca, we are committed to advancing the science of oncology to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of four scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Anti-body-drug Conjugates) to help address unmet clinical needs in a host of cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death. There are many types of cancer disease. For us in Late Development Oncology, to be most effective, we've chosen to concentrate on four key tumor areas; GI, Lung Cancer, Breast Cancer and GU. We currently have over 100 Phase 1, 2, 3 and Lifecycle Management Oncology projects in our robust pipeline. As the Global Clinical Head - GI Cancer and GI Cancer Strategy you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biopharmaceutical companies, we're pioneering innovative research and exploring novel pathways in small and large molecule Oncology. The role is available in multiple sites in the US (Gaithersburg, MD, New York City, Boston) and Cambridge, UK. The Global Clinical Head (GCH) is the most senior medical scientific expert for GI Cancer on the Late Development Oncology team. This role is accountable along with the global clinical heads reporting to this role for all clinical trials under the GI Cancer portfolio, including the benefit/risk. The GCH - GI Cancer and GI Cancer Strategy provides clinical input into overall GI Cancer Steering Council strategy and GI cancer asset strategy. Additionally, this role is responsible for partnering with the Global Product Leaders, Early Oncology leaders, strategy team and other stakeholders to create the GI Cancer strategy across the drug development lifecycle and is accountable for the clinical execution of the strategy. The role will include oversight of the global clinical heads and global clinical program leaders for the GI programs of Late Development Oncology assets (Imfinzi GI, Enhertu GI, Lynparza, Adavo). Global Clinical Head will ensure scientific value creation across lifecycle including initial approval, launch, lifecycle indications through to patent expiry. Responsibilities include: Shaping the strategy and driving the clinical components of the AZ disease area strategy for GI cancers Coherence and quality of the product and indication strategies across the assets The overall benefit/risk of the product or indication (as relevant). Lead the generation of the project-specific clinical strategy and contribute to the overall asset strategy Oversee teams that deliver Target Product Profile (TPP),Target Product Claims (TPC) and maintenance of the Integrated Product Development Plan (iPDP) Full responsibility for the planning, implementation and daily operation of the GI Cancer drug development projects, including responsibility to: Oversee teams that create clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development. Present and defend protocols and clinical development plans at internal governance forums. Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team. Present study updates, interim results, and final headline data to senior management as required. Prepare various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy). Definition and content of product business cases that deliver clinical and commercial value and meet global regulatory authority and reimbursement authority needs. Work with functional management to develop the plans and resolve issues Identify and conduct relevant business and commercial development opportunity assessments in order to maximize clinical and commercial value Deliver product information to support internal and external business portfolio reporting (e.g. CEO briefings, annual results communications etc.). Develop all external information on the product (including publications, regulatory documents, clinical trial registers etc.) Manage and protect the Intellectual Property (IP) assets of the product in consultation with IP and legal experts including leadership of the Patent, Regulatory and Legal Defense Team Main point of contact for TA-Heads and R&D leaders for clinical and scientific components of the product and/or indications Essential for the role Qualified Physician (M.D. degree or equivalent), Medical specialty and sub-specialty training and certification required in Oncology Clinical drug development experience in academic institution or biopharma industry Demonstrated deep clinical and research expertise in GI oncology. Fully conversant with science as it relates to the brand Business acumen - understands unmet market needs, creates a clear path forward, shows how to win Robust knowledge of and evidence of successful oncology product development based on strong science, commercial insights, market research and competitive intelligence Demonstrated understanding of oncology patient selection and stratification including companion/complementary diagnostic development and registration Demonstrated ability to successfully lead, coach, and mentor other physicians/scientists. Proven teamwork and collaboration skills in a global setting Desirable for the role Significant academic, cancer center or industry experience preferred Credible with Key External Oncology Experts, Payers and oncology scientific communities Internationally recognized as an expert in GI Cancer field Developed/delivered multiple complex and large studies Demonstrated success in influencing functions outside of clinical and across geographies. Experience of benefit/risk assessment and creating patient risk management plans. Experience of global regulatory submissions and interacting with major regulatory agencies.... - Permanent - Full-time

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