Clinical Lead MD Required Biopharma

Job description

Clinical Lead (MD required) _ Biopharma YOUR ROLE Act as a medical responsible: Provide medical/scientific input and drive/contribute to 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, publications, etc. Review and sign off all clinical documents related to the clinical studies (e.g. study protocols and study reports) within area of responsibility Conduct medical monitoring for responsible project/study, if applicable Oversees all medical scientific aspects of the trial and provides respective guidance to the trial team Oversee all aspects related to the scientific and medical risks in collaboration with the safety representative Support the review, analysis and interpretation of study data Support communication of study results as assigned Act as a clinical representative in global project/regional team: Propose clinical development strategies in Japan for assigned indication(s)/product(s) in order to establish its safety and efficacy and support registration in the shortest possible time in Japan for information on local medical environment Develop Biomarker strategy in collaboration with the global biomarker team Propose translational studies in collaboration with the global clinical lead and the biomarker team and facilitate the study. Develop, support and/or prepare integrated development plans, submission/registration documents, publications, etc in collaboration with clinical and project team members for assigned indication(s)/product(s) Liaise with (principal) investigators, health authorities, IEC/IRB, consultants, opinion/thought leaders and academic institutions within area of responsibility to deliver on key accountabilities. Participate in cross-functional development project team activities to provide medical/scientific input into e.g. business plan, project strategy, in-/out-licensing activities and Due Diligence as assigned Support business development activities by providing medical-scientific expertise for evaluation of in/out licensing opportunities as appropriate. Provide medical-scientific input to the biomarker strategy in alignment with respective interface functions Act as a clinical representative in global project/regional team: Propose clinical development strategies for assigned indication(s)/product(s) in order to establish its safety and efficacy and support registration in the shortest possible time worldwide Provide medical input to regulatory development strategy and contribute to clinical sections of the Common Technical Document (CTD) WHO YOU ARE Must have at least three years of experience in clinical development. Fluent in English with native Japanese language skills. Must have a strong scientific background with an M.D. Ability to work effectively within a team. Availability for evening-to-night calls to discuss programs/studies with Europe/US-based colleagues. Willingness to visit Key Opinion Leaders (KOLs) and investigators when necessary Effectively drive projects even in uncertain and ambiguous situations