Job Description
Job Description: β’ The Clinical Operations Development Lead (CODL) is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset or across all indications for an asset. β’ Together with the Medical Development Lead (MDL), the CODL co-leads the Clinical Development Team (CDT) and co-owns the Clinical Development Plan (CDP). β’ Ensures the CDP is endorsed by the AST and the Development Management Committee (DMC) and is executed within agreed timelines and budget. β’ Provides strategic input and is accountable for all clinical related aspects within the assigned therapeutic indication/program and in line with the agreed timelines, budget and quality standards as outlined in the applicable Standard Operation Procedures (SOPs) and Work Instructions (WIs). Requirements: β’ Bachelor's degree or University degree β medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience β’ Minimum of 10 years of leading experience in Clinical Development (monitoring, local and global/international trial management) β’ Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry β’ Strong interpersonal and stakeholder management skills β’ Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines. Benefits: β’ Health insurance β’ Retirement plans β’ Professional development opportunities Apply tot his job