Associate Global Development Scientist Director I

Overview

Associate Global Development Scientist Director I supporting late phase AstraZeneca sponsored clinical programs, providing clinical input into trial design, delivery, data review, results interpretation and registration activities.

What you'll do

• Support drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
• Assist in the implementation of protocols and interactions with vendors and CROs, working closely within cross functional team.
• Participate in the development of materials for investigator meetings (e.g., slides, booklets, and presentation materials).
• Assist in triaging and addressing questions regarding scientific and protocol procedures from other study team members and investigative sites.
• Serve as contact with vendors and CROs regarding medical/clinical science issues.
• Support review of clinical data to identify and evaluate study data trends, outliers and protocol violators, and write necessary queries to sites.
• Participate in safety review meetings regarding potential safety events within a clinical study or across the clinical program, and ensure safety updates are shared with the cross functional study team.
• Support review of safety narratives.
• Support preparation of abstracts, manuscripts, publications and poster presentations of clinical study findings and results.
• Support medical affairs, payer and reimbursement activities.
• Assist with drafting assigned sections of clinical reports, dossiers and other documents.
• Support Data Management in the build of the CRF and associated instructions and plans (e.g. CRF completion instructions and Data Review Plan).
• Serve as medical/clinical science representative on study team and collaborate cross-functionally on deliverables such as the protocol, CRF, data listings, TLF and CSR.
• Support creation and review of clinical slides for internal and external meetings.

What you'll need

• Total of 10 to 15 years of experience.
• Life Sciences degree or equivalent PharmD with equivalent experience, or Ph.D. degree in life sciences.
• Industry or academic experience in drug development.
• Detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
• General knowledge of medical monitoring, regulatory approval process in relevant countries, pharmaceutical industry/R&D operations, and marketing and commercial fundamentals.
• Ability to grow and maintain a high level of expertise in the oncology therapeutic area.
• Basic understanding of drug development from molecule to market and knowledge of scientific methodology in the design, conduct and description of clinical research at study level.
• Ability to understand and contribute to drafting documents used throughout the clinical study lifecycle, such as site initiation materials, registration documents, protocols and presentations.
• Outstanding attention to detail and outstanding written communication skills.
• Ability to analyse and summarize clinical results.

Nice to have

• MD preferred.
• Strong preference for Oncology experience.

Details

• Location: Manyata Tech Park, Bangalore.
• Work type: Hybrid, with a minimum of three days per week from the office on average.
• Date posted 05-Nov-2026; closing date 13-Nov-2026.