.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.We are seeking highly qualified candidates to fill the position of Senior Manager, Clinical Scientist (m/f/x).This role could be filled either in Munich or in one of Daiichi Sankyo's European country locations, office-based or remote.The Position:Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares the clinical section of regulatory documents. Collaborates as a team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under the guidance of a higher level. Reviews and oversees the completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Roles & Responsibilities:Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical Study Leader (CSL); Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan, and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation; Oversees recruitment and retention; Establishes and implements contingency plans for shortfalls; Consults & recruits members for DSMB and/or adjudication committee setup; Study outputs: Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK/PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead e.G
