Associate Director Clinical Trials

Mainz, Germany;
London, United Kingdom | full time | Job

As Associate Director Clinical Trials you are responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. You perform activities related with the heading of a project team, the supervision/control of third party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved.

• Lead one or more complex/large scale clinical trial/s in either early or late stage clinical development within a program
• Leading communications, issue escalations and helping the teams within the program to further develop
• Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables
• Manage clinical study timelines for the program(s)
• Ensure inspection readiness throughout the clinical program lifecycle

• A Bachelor’s degree in the life sciences or a university degree in a related field with experience in the health industry (Advanced degree preferred)
• Minimum 10 years of experience in pharmaceutical/biotech or related industry with at least 6 years experience in Global Clinical Development leading cross-functional teams
• Oncology and/or Infectious Diseases experience required, registrational trial experience preferred
• Knowledge and experience working with legislation and international guidelines (ICH-GCP/CFR) for the performance of clinical research projects
• Good communication and presentation skills both written and spoken inclusive of confident, articulate, and professional speaking abilities
• Able to communicate strategy and decisions across different functions