Associate Director Clinical Operations

The client seeks an Associate Director of Clinical Operations to provide key leadership supporting innovative advanced-therapy clinical trials in oncology. In this role, you will help teams deliver studies safely, ethically, and in full compliance with ICH-GCP and applicable regulations, partnering with cross-functional stakeholders, clinical sites, and CROs to execute global programs, manage risk proactively, and ensure high-quality study deliverables. You will collaborate with internal teams to ensure trials meet ICH GCP and federal, international, and local regulatory requirements. Responsibilities include managing and forecasting trial budgets and timelines, driving alignment on performance indicators, and developing major study documentation such as protocols, CRFs, SAPs, CSRs, and manuals. You will also evaluate KPIs, KRIs, and SOPs to identify gaps and propose solutions that improve compliance and efficiency, while contributing to regulatory filings domestically and internationally. Requirements include a bachelor’s degree in life sciences or a related field, along with 10+ years of progressive clinical operations experience in oncology, including at least 5 years within a biopharmaceutical organization. The role also expects experience overseeing CRO selection, contracting, and management, as well as the ability to mentor and develop clinical operations team members and interact regularly with senior management on project and departmental initiatives. You may oversee a team to achieve organizational goals. Confidential