Associate Global Development Scientist Director I

Job Title: Associate Global Development Scientist Director I Career Level – E Location: Manyata Tech Park, Bangalore Work Type: Hybrid Total years of experience: 10 to 15 years Introduction to role: The Global Development Scientist 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 members, Site Management & Monitoring (SMM), field based liaisons, and site personnel. The Global Development Scientist and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a clinical program. This includes the shared responsibility with Clinical Operations team members 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). The Global Development Scientist 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 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. About AstraZeneca: AstraZeneca is a global, science-led, patient-focused pharmaceutical company that focuses on the research, development, and commercialisation of prescription medicines. We aim to transform the lives of patients with improved outcomes and a better quality of life. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work. Accountabilities: Clinical Development Responsibilities: • 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. Serves as contact with vendors and CROs regarding medical/clinical science issues. • Support review of clinical data to identify and evaluate study data trends, outliers, protocol violators, etc and write any necessary queries to be communicated to sites to ensure data accuracy and completeness of the assigned 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. Support review of 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, p