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 clinical science team based in Europe we are seeking highly qualified candidates to fill the position Director Clinical Science (m/f/x) This global role could be filled Europe-wide, in one of the Daiichi Sankyo offices locations The Position: In this role, the team member oversees / key contributor to a global Ph1, 2 or Ph3 trial.Leads clinical study protocol preparation and amendments.Contributes to the medical monitoring and study strategy and to regulatory documents.Collaborates as team member with AROs/CROs.Drafts development plansand sections of submission documents.Provides medical and/or scientific direction to the study team.Partners with Clinical Operations for a successfully delivery of the study.Represents Clinical Science on Project Teams.Roles and responsibilities: Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, ed-it 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; Leads protocol development and 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.review Tables/Listings/Graphs before database lock and quality check of data; Works with BD&O to ensure SAP update External collaboration: Consults with internal experts and external KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes effective communication between CRO / vendors / ARO Additional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares material for KOL interactions on a program based need; Involvement with in-licensing and acquisitions on individual due diligence activities Education & Professional Experience: Master degree in Life Science or Pharmacy or equivalent, PhD/PharmD or equivalent is a plus Postgraduate training in oncology or clinical research is a plus 3+ years of relevant clinical experience in industry with PhD, PharmD or 5+ years of relevant clinical experience in industry with Master's degree Strategic Thinking Clinical Trials Knowledge Scientific and Oncology Knowledge Influencing Skills Scientific Knowledge Drug Development Critical Thinking Efficient communications Problem solving Strong Team Player Team Leadership Ability to travel up to 30% globally Why work with us?Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients' lives for the better.We can only achieve this ambitious goal together.That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity.Here, you will have the opportunity to grow, think boldly, and contribute your ideas.If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
