The Senior Manager, Clinical Safety Scientist, will handle aspects of signal identification, evaluation, and risk mitigation across therapeutic areas, in collaboration with product safety leads. This position proactively creates communication plans for important safety topics and identified risks. This position may serve as primary author for certain safety documents and regulatory submissions (NDA/BLA in US and MAA in EU). Additionally, this position project manages larger Phase 3 Studies, Safety Management Team (SMT) meetings and supervises junior scientist to work together as a team. This position works closely with CSPV staff, SMT members and other functions.

Roles and responsibilities:

Oncology Product Risk Management support for pivotal clinical studies and BLA/MAA activities

• A key participant in developing and implementing the risk management strategy for assigned oncology products
• Works with Product Safety Physician for pivotal clinical study maintenance
• Works with Product Safety Physician to support regulatory submissions (NDA/BLA in US and MAA in EU) and develops the strategy for risk minimization activities for post- marketing

Risk Management (Signal identification, evaluation, mitigation) and Safety Communication

• Support Product Safety Physician for signal discussion at Safety Management Team (SMT)
• Independently integrates and analyses safety data from multiple sources to deliver comprehensive conclusions
• Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately
• Develops strategy for communicating safety information internally and externally in collaboration with product safety lead
• Leads the development of safety communication documents and aggregate safety reports

Project Management

• Serves as Project Management for Signal Management and Safety Management Team devoted to larger Phase 3 products and ensures adherence to project timeline
• Responsible for Signal Tracking and Deviation Management with safety related activities (e.g. RMP)