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Clinical operations director (ro)

Ro
1925 GlaxoSmithKline
Pubblicato il 26 marzo
Descrizione

Job Purpose: You will lead and develop the program level operational strategy and delivery plan for an asset, ensuring studies run safely and efficiently.You will work with cross-functional partners to keep programs inspection ready and to deliver high-quality data for regulatory interactions.We value clear judgement, practical problem solving, and collaborative leadership.This role offers strong learning and career growth, and the chance to make meaningful impact aligned with GSK's mission of uniting science, technology and talent to get ahead of disease together.Key Responsibilities: Lead asset-level clinical operations planning to maintain inspection readiness and regulatory deliverables.Contribute to the development of the Clinical Development Plan and Integrated Evidence Plan Represent Global Clinical Operations functions at the asset level.Coordinate cross-functional partners (clinical, biostatistics, clinical supplies, safety, and vendors) to support timely data deliveries.Oversee vendor selection, contracting input, and operational oversight for outsourced clinical activities.Model scenarios for optimal asset/study delivery linked to value drivers and drives decisions presented to governance boards Maintain and drive implementation of asset-level operational risk and mitigation plans.Drive innovative approaches to study execution through external facing advances in technology and sciences, by identifying and embracing risks and opportunity Provide strategic guidance and leadership to Study Delivery Teams to ensure clinical project goals are met.Prepare and respond to data requests and contribute to materials for regulatory submissions.Basic Qualifications: Advanced degree in MD, PharmD, PhD or related field, or equivalent clinical experience.8+ years of clinical development experience, with oncology exposure.3+ years of experience leading R More detailed information on the total reward package applicable to your role will be supplied during the recruitment p

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