ClinicalDevelopmentDirector

**Job Description Summary** The Clinical Development Director (CDD) is the clinical/scientific expert and if assigned the clinical development lead of a section of a global clinical program and/or trial. (e.g., an indication, a new formulation, or a specific development phase) or a large, complex trial, under the leadership of the GPCH. The CDD may be assigned to have a team leadership role for sections clinical programs and/or global clinical trials, depending on the size, nature and complexity **Job Description** Title: *Clinical Development Director Office Location: London UK or Dublin Ireland #LI-Hybrid Hybrid (12 days per month on-site) **Major accountabilities:** * Supports and if assigned leads delivery of all assigned clinical deliverables in the assigned section of a clinical program. Clinical deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review program specific standards, clinical components of regulatory documents/registration dossiers, and publications * Contributes and if assigned leads development and delivery of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) * Drives execution of the section of the clinical program in partnership with global line functions, in particular clinical operations, trial leaders and data management/analysis, and regional/country clinical development associates * Ensures ongoing clinical and scientific review of clinical trial data. * Work in close collaboration with the data management and statistics teams to ensure proper data quality and analysis of clinical trial results. * May be the Program or Function Manager of associates (e.g., CDD or associate CDD * Supports GPCH in assessing overall risk-benefit of the molecule for the a