Director Clinical Development (M/F/X)

.Passion for Innovation. Compassion for Patients.With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas : The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.For our European headquarters in Munich or in one of our European affiliates we are seeking highly qualified candidates to fill the position :Director Clinical Development (m / f / x)The Position :Roles & Responsibilities :Study Strategy : Clinical study (co) leader (CSL); For large or complex Phase 2 or 3 studies : Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develops biomarker strategy in collaboration with TMCP, Collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicable- Study planning and execution : As CSL for Phase 2 or 3 studies : Provides input on major milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management on potential risks to study deliverables, Provides input on ICF creation, Oversees recruitment, retention; - establishes andimplement contingency plans for shortfalls, Consults & recruits members for DSMB and / or adjudication committee setup; Interacts with KOLs and PIs to plan study and monitor completionStudy outputs : For Phase 2 or 3 studies : Drafts responses to IRBs and HA, Collaborates with TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Performs quality assessment e.g