Clinical Development Director 18 month Contract Hybrid or remote Job Purpose The Clinical Development Director (CDD) is the clinical/scientific and clinical development expert and provides leadership and support to clinical development deliverables and activities within a defined global clinical development program and/or global clinical trial (e.g. clinical development plan, clinical trial protocol), under the leadership of the GPCH. Major Activities 1. 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 and program specific standards, clinical components of regulatory documents/registration dossiers, and publications 2. Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations. 3. Leads development 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) 4. Oversees/conducts ongoing clinical and scientific review of clinical trial data with medical monitor, Clinical Scientific Expert(s)...