Support the planning and execution of the safety strategy for Oncology assets during the entire lifecycle of the drug and during due diligence activities.

Main responsibilities

• Supports the Safety Leads and Product Safety Teams (PSTs) to translate nonclinical and clinical safety findings to facilitate benefit-risk decision making and risk mitigation for oncology products in clinical development as well as on the market.
• May lead development and implementation of an asset safety strategy with support of PST-L or management
• Leads the review and synthesis of scientific safety data for critical regulatory and clinical documents — including IB’s DSURs, PSURs, RMPs CSRs, etc. - ensuring medical accuracy, scientific rigor, and clarity of content across oncology assets
• Facilitate scientific connections and interactions, info exchange across assets within the safety teams
• Prepare material on competitive intelligence, current disease state and standard of care for key indications/ disease states
• Supports GPS TA  in assigned due diligence activities for Oncology.
• Compiles draft slide presentations for internal and external meetings as required
• Interacts with and influences other cross functional departments (e.g. Clinical Development, Statistics, Regulatory Affairs, Clinical Pharmacology, Medical Affairs), as needed, to ensure the successful development, design and implementation of comprehensive safety assessments to support study participants in Oncology studies.
• Drives process improvement and change management for the Oncology Safety team in conjunction with enterprise-wide and functional area plans.