Associate Director of Clinical Operations

Job Summary

A company is looking for an Associate Director, Clinical Operations.

Key Responsibilities

• Lead and manage the planning, execution, and reporting of clinical trials, including protocol writing and site management
• Collaborate with internal and external teams to develop clinical strategies and trial designs, while overseeing investigator meetings and budget negotiations
• Ensure compliance with regulatory requirements and manage clinical study timelines and data review processes

Required Qualifications

• Bachelor's degree in a scientific discipline with a minimum of 7 years of relevant experience in clinical research
• Comprehensive knowledge of drug development processes and clinical trial design
• Experience with Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• Ability to manage and mentor direct reports, and proficient in Microsoft Word and Excel
• Prior experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) is preferred