Clinical Research

• Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs
• Collaborate with other medical and clinical scientific experts CRDs or DSDs in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction
• Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc…)
• Provide appropriate medical input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
• Develop the clinical part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc…) and answers to questions from health authorities

Senior Clinical Research Director, Rare

Senior Principal Biostatistician