Director Clinical Development

SanofiCambridge, MA
486d

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About The Position

The Director Clinical Development is a pivotal role within our innovative global healthcare company, which is dedicated to combating infectious diseases through the delivery of over 500 million vaccine doses annually. This position requires a clinical, medical, and scientific expert who will support the translation of a target product profile into a feasible Clinical Development Plan (CDP). The role demands a comprehensive understanding of the scientific environment, resource possibilities, clinical feasibility, and the importance of timely execution. The Director will be responsible for leading the clinical study team, necessitating strong leadership and communication skills, as well as the ability to inspire and operate within multidisciplinary and multicultural teams. In this role, the Director will have global responsibility and ownership for the Clinical Strategy, the respective Clinical Development Plans (CDP), and study protocols for various projects and programs. It is essential that the CDPs align with the Target Product Profile (TPP) and the Integrated Evidence Generation Plan (IEGP), ensuring global consistency across regions. The Director will also provide clinical and R&D expertise, guidance, and direction tailored to the specific region or country in which they operate. A critical aspect of this role is establishing the necessary conditions to ensure the safety of all subjects involved in clinical trials for the vaccine development candidates under their oversight. Additionally, the Director will provide clinical expertise and support for regulatory activities, including Health Authority meetings, communications, and CTD submissions.

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