the client is seeking an experienced Associate Director, Clinical Development Trial Lead to drive the execution of complex global oncology clinical trials. This highly visible leadership role will oversee key aspects of study execution, including strategy, enrollment, budgets, partnerships with clinical research organizations, and coordination across cross-functional teams, while supporting clinical development decisions at a global scale.
Responsibilities include independently leading cross-functional study teams to develop and execute complex clinical trials and ensuring delivery of clinical milestones with quality, on time, and within scope and budget. The role will demonstrate independent leadership and influence with study teams, management, and business partners, proactively identify issues and resolve them, and apply expertise in therapeutic and clinical drug development to influence study design and program-level decisions while considering regional needs. It will also coordinate and facilitate the collection of regional input for study teams and act as a single point of accountability for the Trial Master File for assigned trials, partnering with functional record owners to keep documentation current and inspection ready.
The Associate Director will ensure inspection readiness for assigned clinical trials, including timely documentation of deviations and preparation of materials such as storyboards or issue summary documents for high-risk areas and topics. The role will report, manage, and interpret trial information to ensure completeness and accuracy across relevant systems and will drive regional clinical operational processes and methodologies. Qualifications include a bachelor’s degree in a scientific or health-related field (preferred), at least 5+ years of clinical research experience with strong knowledge of the clinical research process, a minimum of 5 years of clinical trial experience, oncology experience across early and late phase clinical trials, and prior site-level or affiliate experience as well as familiarity with local/country regional requirements; periodic travel to scientific or regional meetings is expected.