Clinical Operations Development Lead

Remote, USA Full-time
Job Description: • 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. • Together with the Medical Development Lead (MDL), the CODL co-leads the Clinical Development Team (CDT) and co-owns the Clinical Development Plan (CDP). • Ensures the CDP is endorsed by the AST and the Development Management Committee (DMC) and is executed within agreed timelines and budget. • 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: • Bachelor's degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience • Minimum of 10 years of leading experience in Clinical Development (monitoring, local and global/international trial management) • Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry • Strong interpersonal and stakeholder management skills • Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines. Benefits: • Health insurance • Retirement plans • Professional development opportunities Apply tot his job
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