Lead Clinical Scientist, Research and Development

hace 14 horas

Girona, Gerona, España Daiichi Sankyo Europe A tiempo completo
About Daiichi Sankyo Europe

Dedicated to discovering, developing, and delivering innovative treatments that enhance the quality of life for patients worldwide, Daiichi Sankyo Europe is a leader in the pharmaceutical industry. With over 120 years of experience and a global presence in more than 20 countries, our team of experts strives to push the boundaries of medical science and improve patient outcomes.

Job Overview

We are seeking a highly skilled Lead Clinical Scientist to join our Research and Development team in Munich, Germany or one of our European country locations. As a key member of our clinical operations team, you will be responsible for overseeing non-pivotal trials, preparing regulatory documents, and collaborating with AROs/CROs.

Key Responsibilities
  • Study Strategy: Provide 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; Develop 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. 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;
  • Additional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact with KOL and prepares material for KOL interactions on a program-based need;
Requirements
  • Master's Degree or equivalent preferred;
  • PharmD or equivalent preferred;
  • PhD or equivalent preferred;
  • Postgraduate training in TA or related specialty, or equivalent preferred;
  • 4 or More Years with PharmD, PhD and relevant clinical experience preferred;
  • 7 or More Years with Master's degree and relevant clinical experience preferred;
Benefits and Opportunities

As a Lead Clinical Scientist at Daiichi Sankyo Europe, you will have the opportunity to work on complex clinical trials, collaborate with international teams, and contribute to the development of innovative treatments. Our company offers a competitive salary package, comprehensive benefits, and opportunities for professional growth and development. We are committed to fostering a culture of inclusion and diversity, where everyone has the chance to grow, think boldly, and contribute their ideas.

We offer an estimated salary of €80,000 - €110,000 per year, depending on experience and qualifications. If you are passionate about improving patient outcomes and have a strong background in clinical research, we encourage you to apply for this exciting opportunity.

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