AstraZeneca
Job title:
Global Development Scientist Associate Director, Late Development Oncology
Company:
AstraZeneca
Job description
Do you have expertise in, and passion for clinical drug development? Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? Join the team at the heart of AstraZeneca dedicated to Oncology, committed to following the science.About AstraZenecaAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation 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 doGlobal Development Scientist Associate Director, is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working collaboratively and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field based liaisons, and site personnel. You will partner with a Global Development Medical Director in the clinical aspects underpinning a clinical program. Both will share the responsibility with Clinical Operations team in the planning and execution, including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies. This includes 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 NDA/BLA).In this role, you may also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or cross tumor area working groups depending on the level of experience.As a key member of the clinical team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of collaborators 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.Other responsibilities include but are not limited to:Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.Assists in the implementation of protocols and interactions with vendors and CROs, working closely within cross functional team. Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials). Assists in triaging and addressing questions regarding scientific and protocol procedures from other study team members and investigative sites.Support review of clinical data to identify and evaluate study data trends, outliers, protocol violators, etc and write any vital queries to be communicated to sites to ensure data accuracy and completeness of the study.Participate in safety review meetings regarding potential safety events within a given clinical study or across the assigned clinical program. Ensure updates to safety information is shared with cross functional study team. Help review safety narratives.Supports preparation of abstracts, manuscripts, publications and poster presentations of clinical study findings and results throughout the life cycle of the assigned study or product, as applicable. Supports medical affairs activities, payer and reimbursement activities.Assists with drafting assigned sections of clinical reports, dossiers and other documents.Support Data Management in the build of the CRF and all associated instructions and plans (e.g. CRF completion instructions and Data Review Plan).Serves as medical/clinical science representative on study team and collaborates cross-functionally on applicable deliverables during study life cycle (e.g the protocol, CRF, data listings, TLF, CSR etc.)Analyse and summarise clinical results.Responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures.Essential for the roleBachelor’s degree with focus on life sciences or equivalentIndustry or academic experience in drug development requiredDetailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.General knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.Ability to grow and maintain a high level of expertise in oncology therapeutic area.Basic understanding of drug development from molecule to market and demonstrates knowledge of scientific methodology in the design, conduct and description of clinical research, at a study level.Ability to understand, and contribute to the drafting of documents used throughout the clinical study lifecycle, such as site initiation materials, registration documents, protocols, and presentationsOutstanding attention to detail and outstanding written communication skills.Strong preference for Oncology experienceDate Posted 22-lip-2024Closing Date 31-lip-2024AstraZeneca 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.
Expected salary
Location
Warszawa, mazowieckie
Job date
Wed, 24 Jul 2024 00:19:07 GMT
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