◦ Line manager for up to 21 employees ◦ Member of Clinical Development Management Group ◦ Participate in strategic planning regarding strengthening of Clinical Development◦ Responsible for the delivery of clinical program (first in human to phase 3) in accordance with drug development plan within oncology◦ Outsourcing of clincial trials and vendor management◦ Development of monoclonal antibodies for treatment of cancer

◦ Line manager for a team of 5-8 International Clinical Trial Managers, Lead Clinical Research Associates, CRAs and Clinical Trial Administrators◦ Act as the project leader for the clinical development of monoclonal antibodies for the treatment of cancer (First in Human to phase 3)◦ responsible for preparation of clinical development plans (CDP) involving colleagues within relevant professional areas

◦ Line-management of International Trial Managers and Clinical Trial Administrators working with oncology trials◦ Member of Global Project Team◦ Responsible for preparation and implementation of clinical trial activities in accordance with Product Business Plan (PBP) and the Clinical Development Plan(s).◦ Ensure consistency within the clinical programme

• Planing and co-ordination of clinical trial activities• Preparation and Implementation of Clinical Trial Protocols• Outsourcing of Clinical Trials• Therapeutic experience in oncology, hematology and growth defiency

◦ Establishment of and contact to clinical advisory board◦ Preparation of clinical development plans◦ Preparation and maintenance of Investigators brochure◦ Preparation of protocol synopses for the individual trials and writing of trial protocol via CRO◦ Overall management of clinical trials (phase I and II) within the clinical development plan for a product through CROs

◦ Monitoring of clinical trials including pre-study visits, periodic monitoring visits and close-out visits◦ Plan and conduct international clinical trials within Oncology (phase III)