Associate Director Clinical Operations

This Associate Director, Clinical Operations role is a key leadership position supporting advanced-therapy clinical trials in oncology. You will help clinical teams deliver studies safely, ethically, and in compliance with ICH-GCP and applicable regulations. The role partners with cross-functional stakeholders, clinical sites, and external partners to execute global programs, proactively manage risk, and ensure high-quality study deliverables. You will lead and guide clinical trial teams, collaborating with internal functions, clinical sites, and CRO partners to conduct global clinical programs in a safe, ethical, and compliant manner. Responsibilities include ensuring trials adhere to ICH GCP and relevant federal, international, and local regulatory requirements, as well as managing and forecasting trial budgets and timelines aligned to organizational objectives. You will also develop core study documents such as protocols, CRFs, SAPs, CSRs, and manuals, evaluate KPIs/KRIs and SOPs to identify gaps and propose improvements, and contribute to regulatory filings domestically and internationally. Additional expectations include partnering with US, EU, and international colleagues, as well as investigators and CROs, to identify risks and develop effective trial plans. The role may involve overseeing a team and includes mentoring and developing Clinical Operations team members through staffing, performance management, and talent development, along with regular interaction with senior management on project and departmental initiatives. Qualifications include a bachelor’s degree in a life sciences or related field, progressive clinical operations experience in oncology, and experience in biopharmaceutical organizations, including overseeing CRO selection, contracting, and management; further, familiarity with evaluating clinical operations performance and process improvement activities is expected for this leadership position. Confidential