The Role

Senior Clinical Development Lead

Main duties:

• Clinical Leader of the global clinical development of small molecules/biological products of the Hematology pipeline
• Responsible for the clinical assessment of new inlicensing opportunities aiming to the expansion of the R&D Hematology pipeline.
• Represent the Clinical Development function in the international compound development team
• As Leader of the clinical team being accountable for the efficient execution of clinical studies, from protocol design, start up activities, competent authorities approval, ongoing medical monitoring, data analyses and reporting, in accordance with assigned budget and timelines.
• Key contributor to the identification of innovative target /biomarkers for precision medicine approaches.
• Preparation of the clinical section of the Registrative Dossier and expert representative at regulatory authorities meeting.
• Represent TA Hematology expertise at meetings with competent authorities relevant to clinicaI development plans/study protocols/ dossier submission (e.g, scientific advice, pre- lND, end of phase I meeting etc)
• Identification and collaboration with KOLs and Expansion of the network of strategic scientific collaboration with academic Hematology institutions and development partners.
• Representative of the Hematology Expertise at Steering Committee/ Advisory Board/Data, Safety Monitoring Board at study and/or project level.
• Together with medical affairs and other key functions develop the publication plan and leading the preparation publications in medical journals or presentation to congresses.
• Contribution to the preparation of corporate presentation on Hematology portfolio, press release etc.
• Contribute to the global product strategy through deep understanding of the medical landscape of the relevant geographies, sharing insights through engagement with external experts
• In collaboration with the Medical Affairs Team contribute to the strategic direction for study design and execution for local and global medical affairs studies .Direct management or supervision of the technical clinical team activities, securing the full alignment with the core project team assigned tasks

Personal Attributes

• MD degree from an accredited medical school
• Broad Clinical and disease knowledge base in hematological malignancies and solid tumors
• At least 5 years of relevant Clinical Development experiences in Hematology-Oncology
• Management and leadership experience in a direct report and non-direct report framework with complex cross-functional responsibilities
• Ability to work well and cohesively in cross-functional teams (team-player)
• Excellent problem solving and decision-making skills
• Fluent in English
• Experience with Pre-clinical and Translational Research (preferable)
• Experience of successful design and execution of clinical programmes used to support drug development in compliance with scientific and regulatory guidelines