Advisor - LEM - Eli Lilly and Company : Job Details

Lead immunogenicity and biomarker activities and other clinical diagnostics in compliance with Lilly policies, local and international regulations, laws, guidance (e.g. FDA, EMA, ICH, etc.), Good Clinical Practices (GCPs) and corporate integrity agreements, as applicable. Lead and collaborate with clinical teams to identify, develop and implement strategies to fully characterize, minimize and monitor the impact of immunogenicity on clinical outcome (benefit and risk) for patients treated with a Lilly biologic and to provide data analysis and interpretation relevant to these strategies. Develop, define, and deliver immunogenicity and biomarker related regulatory submission strategies and documents for Lilly assets. Develop and implement novel biomarker strategies to inform mechanism of action, efficacy, and safety of Lilly assets. Advise and influence project teams regarding clinically meaningful translational opportunities. Coordinate consultative and collaborative activities with...Advisor, Clinical, Leadership, Project Lead, Business Services, Regulatory, Development