Opportunity Details

The Sr. Director, Clinical Operations - Ph III will be responsible for leading global Phase 3 study executions, managing CROs and vendors, overseeing study monitoring and strategic development, ensuring compliance with study plans, managing budgets, and mitigating potential risks. This role will focus on start-up activities globally, ensuring adherence to development plans, managing study timelines and enrollment goals, and creating study documents like contracts and protocols. The ideal candidate will have over 10 years of experience in clinical trial management, including supervising staff and CROs, as well as experience in late-stage drug development and study start-ups.

The primary job responsibilities of the Sr. Director, Clinical Operations - Ph III include leading Phase 3 study operations, managing CROs and vendors, overseeing study monitoring and data collection, and leading clinical strategy discussions. This role will also assess strategy feasibility, manage study budgets, address compliance and risk issues proactively, and ensure adherence to development plans by CROs and internal teams. The ideal candidate will have a background in hepatology, a strong understanding of GCP, ICH, and relevant CFRs, and excellent project management and communication skills.

Our client is a company that values lasting relationships with exceptional biopharmaceutical talent and takes great care to protect personal information. They are committed to building a team that is resourceful, creative, committed to confidentiality and teamwork, and aligns with company values. If you are interested in joining their network or making a career change, you can expect to work with a team that prioritizes ethics and professionalism.