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
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