Do you have expertise in Oncology clinical drug development and passion for developing late phase clinical program strategies? Then AstraZeneca might be the place for you!
About AstraZenecaAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases. We are more than one of the world's leading pharmaceutical companies.
Oncology Research & Development, Late Development OncologyOur ambition is to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Focusing on cutting-edge science with the latest technology to achieve breakthroughs. AZ is a place built on courage, curiosity, and collaboration - we make bold decisions driven by patient outcomes.
Within Late Development Oncology, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. Supportive team players, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges.
What you'll doAs Global Development Medical Directors, we are diligent and committed to our science-driven and patient-centric approach, with a sharp focus on improving clinical outcomes. The focus of this position will be breast cancer. The Global Development Medical Director is an important part of the Clinical Project Team (CPT) and Global Study Team (GST) working synergistically and cross-functionally (in a matrix environment) with other CPT, GST, and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.
The Global Development Medical Director and counterpart Global Development Scientist work collaboratively in the clinical aspects underpinning a product. Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies, including providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e., clinical input to (s)NDA/(s)BLA.
The Global Development Medical Director plays a critical role in the medical monitoring of a clinical study ensuring safety to patients. They share responsibility with Clinical Operations team members in the planning, execution, and closure of a clinical study. The Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset, cross-tumor working groups depending on the level of experience.
This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws, and adhere to Good Clinical Practice and regulatory requirements. Depending upon experience level, the role could mentor the development of less experienced members of the clinical team and may involve direct line management of other physicians or scientists. The focus of this position will be breast cancer indications and portfolio.
Responsibilities includeResponsible for ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with FDA, EMEA, ICH, and GCP guidelines as well as AZ SOPs regarding safety.Work cross-functionally within clinical product teams (CPT) to ensure the clinical strategy is translated into the development of the study concept document, study protocol, and related documents.Significant contributor to the development of program strategy for assigned compound(s)/programs and work with GPT/CPT members to develop a compelling business case for governance approval.Provide expert clinical input to influence the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets the strategic program objectives.Participate or lead as needed the review and assessment of new opportunities and ESRs.Accountable for the relevance and accuracy of clinical science underpinning a clinical study based on detailed scientific review.
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