Senior Director, Global Clinical Operations, Study Start-Up

Job Description: • Lead the strategic planning and execution of study start-up activities across clinical programs, ensuring rapid, high-quality site activation. • Provide leadership to cross-functional teams, oversee budgets, engage key stakeholders, and drive continuous process improvements. • Develop and implement activation strategies, manage regulatory and ethics submissions (IRB/EC and Health Authorities), oversee site contract and budget negotiations. • Monitor operational KPIs, ensure audit and inspection readiness, and lead end-to-end study start-up activities. • Drive continuous improvement initiatives focused on reducing activation timelines and increasing predictability, and evaluate and introduce innovative tools. • Champion change management related to new systems, SOPs, and operational models. Requirements: • Bachelor’s degree in a life sciences discipline required; advanced degree preferred. • At least 12 years of clinical research experience, with 6 years in clinical operations leadership roles in sponsor/biotech/CRO settings. • Proven track record of operational excellence in delivering clinical trials, ideally including innovative approaches to speed up study start-up and site activation. • Extensive experience as a direct line manager with responsibility for performance management and team development. • Expert knowledge of global clinical trial regulations (ICH-GCP, FDA, local regional authorities). • Strong expertise in global study start-up processes—including clinical trial package preparation, submissions, contracting, and site activation. • Advanced risk management and problem-solving abilities. • Strong financial acumen including budget forecasting and cost oversight. • Ability to work independently and manage multiple priorities effectively. Benefits: • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness • Annual bonus plan • Incentive compensation plan • Employee Stock Purchase Plan