Clinical Development Manager

PE Global is currently recruiting for a Clinical Development Scientist (Cardio) for an 18 month contract role with a leading multinational Pharma client based in London. 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. Job Responsibilities 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. Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations. 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) Oversees/conducts ongoing clinical and scientific review of clinical trial data with medical monitor, Clinical Scientific Expert(s) with appropriate oversight from Medical Lead. Work in close collaboration with the data management and statistics teams to ensure proper data quality and analysis of clinical trial results. Inspection Readiness and interaction with QA - risk assessments, audit preparation, mock interviews, storyboard and presentation prep; Author and/or review abstracts, presentations and manuscripts for accuracy of clinical data and content May be the Program Manager of other associates (e.g., CSE) Provides support to Sr CDMD and/or GPCH in monitoring and safety data and signals the molecule for the assigned section of the clinical trial, may be a member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with the medical monitor, CDMD and Patient Safety As a clinical development expert, may support the GPCH or CDH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE