Signal Management & Innovation Lead

Job Summary:The Signal Management and Innovation Lead position leads Amgen safety signal management processes and activities and serves as a key strategic partner within the Integrated Signal Management team, focused on identifying, evaluating, and implementing emerging technologies and AI/ML-enabled analytical tools in collaboration with Data Science, Digital Technology, and AI & Data Science teams. This role will lead the team to bridge scientific, technical, and business functions to co-develop innovative surveillance capabilities that monitor the safety and quality of Amgen products.

Key Activities:

Technology Scouting & Evaluation

• Monitor and evaluate industry trends, emerging technologies, academic research, and vendor solutions related to AI/ML for post-market safety and product complaints surveillance.
• Maintain a landscape of external vendors offering signal detection, NLP, and data analytics solutions relevant to product surveillance.

Collaboration & Innovation Development

• Partner with the ISM Data Science team to assess feasibility, develop prototypes, and deploy AI/ML models for signal detection and augmentation of signal assessment
• Engage with stakeholders (e.g., TA Safety) to identify unmet needs and prioritize use cases.
• Leads AI projects prioritized by GPS
• Facilitate workshops or ideation sessions to shape innovation roadmaps and pilot initiatives.
• Promote adoption of industry best practices and ensure compliance with regulatory guidance on AI/ML and surveillance in the context of combination products.
• Perform regulatory impact and risk analysis of proposed solutions
• Develop internal guidelines and documentation for use of advanced analytics in surveillance activities.