Senior Manager, Clinical Research Leader

hace 1 día

Barcelona, Barcelona, España Daiichi-Sankyo Europe A tiempo completo

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: Our Specialty Business aims 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:

As a key member of our Clinical Development team, you will oversee typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). You will prepare the clinical section of regulatory documents, collaborate with AROs/CROs, and draft development plans, protocol profiles, and sections of submission documents under the guidance of a higher level. You will also review and oversee the completion of clinical trial protocols, provide medical and/or scientific direction to Clinical Operations, and represent Clinical Development on Project Teams.

Key Responsibilities:
  1. Study Strategy: Provide strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP. Review patient population and protocol compliance for consistency with study strategy. Develop biomarker strategy in collaboration with Translational Medicine/Clinical Pharmacology. May act as Clinical Study Leader (CSL).
  2. Study Planning and Execution: Provide input on major milestones of trial, clinical trial plan, and contingency planning. Analyze and update management on potential risks to study deliverables. Provide input on ICF creation. Oversee recruitment and retention; establish and implement contingency plans for shortfalls. Consult and recruit members for DSMB and/or adjudication committee setup.
  3. Study Outputs: Draft responses to IRBs and Health Authorities. Collaborate with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK/PD measurements. Review emerging clinical data regularly. Lead dose-escalation meetings. Perform quality assessment with Delivery Lead.

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