Act as Medical Responsible in pre-PoC project teams to provide medical/scientific input into e.g. project strategy, as assigned.
Design and drive execution of early clinical development strategies for assigned projects in order to establish a clear path to First-in-Man (FiM) to Proof-of-Confidence (PoC) and related Go/No Go criteria in close collaboration with Clinical Pharmacology and Global Clinical Operations.
Drive and support the development and preparation of early clinical development plans, study concept sheets, and study protocols in collaboration with project team, representing the respective functions.
Provide medical/scientific input and drive the creation of relevant clinical documents or parts thereof to ensure high quality of e.g. study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
Review and sign off all clinical documents related to FIM and PoC studies (e.g. study protocols and study reports), supervise the review, analysis and interpretation of study data. Support communication of study results as assigned.
Liaise with (principal) investigators, health authorities, IEC/IRB, consultants, opinion/thought leaders and academic institutions within area of responsibility.
Drive exploratory analyses of completed clinical trials to enhance quality of subsequent trials in collaboration with Head of Translational R&D Osteoarthritis (OA) and Head of Biomarker and Clinical Epidemiology OA.
Liaise with colleagues in Global Development & Medical (GDM) to cause harmonization of OA-related development activities in Global Research & Early Development (GRED) and GDM.
Support/Contribute to annual budget and resource planning.
Support business development by providing scientific and medical input to in-licensing opportunities.
Increase scientific knowledge in the OA Research and Early Clin. Dev. organization by contributions to OA Disease Task Force. Assist in organizing scientific development activities within OA Research and Early Clin. Dev., such as inviting external speakers.
(im Bereich Klinische Forschung, Projektmanagement, Forschung & Entwicklung)