Associate Director, Clinical Operations

Role: Associate Director, Clinical Operations, leading and managing end-to-end clinical trial activities across therapeutic areas within biopharma. Objectives include ensuring trial execution in compliance with regulatory standards, overseeing study design, site selection, vendor management, and data review. Responsibilities encompass developing study protocols, managing timelines and budgets, facilitating regulatory submissions, and mentoring staff. Requirements: Bachelor's degree in a scientific discipline, minimum 7 years of experience in clinical research within pharma, biotech, or CRO settings, with knowledge of drug development, GCP, GMP, ICH guidelines, and experience supporting IND/NDA submissions. Preferred skills include prior field monitoring, medical writing, project management, and proficiency with Microsoft Project and PowerPoint. High-value biopharma specifics involve clinical development in rare diseases, with up to 20% travel expected. The role demands collaboration with internal teams and external investigators, with an emphasis on regulatory compliance, clinical data integrity, and team leadership. Work setup: travel up to 20%; location type not specified.