Director Clinical Development

Company Description

The (Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product.

Specific responsibilities include: design of clinical trials (any phase as required by the clinical development program, including phase IV), clinical protocol development, medical monitoring of clinical trials, analysis of study data, contribution and review of clinical study reports, of clinical modules of registration dossiers, of briefing books for interactions with Health Authorities.

The (senior) Director Clinical Development will represent and defend the clinical strategy during in the MAA regulatory review process across multiple geographies and in meetings with Health Authorities.

The individual will closely work with other RD functions to ensure the successful progress of projects and clinical trials and will interact with the scientific and patient community to ensure ...