Associate Director, Clinical Operations (SF Bay Area)

Role: Associate Director of Clinical Operations responsible for leading clinical studies across all phases, ensuring timely, compliant, and quality execution within a global biotech setting focused on chronic diseases. Responsibilities: oversee study start-up, conduct, and close-out; develop operational plans; manage budgets, timelines, and vendors; mitigate risks; ensure regulatory compliance; prepare and review study documentation; collaborate with cross-functional teams including Data Management, Biostatistics, Safety, and Medical Affairs; lead site and investigator engagement and oversee safety and quality standards; promote continuous process improvements. Qualifications: Bachelor's degree in a scientific or health-related field; 8+ years in clinical operations within pharma, biotech, or CRO, with at least 6 years in roles such as CRA or CTM; experienced managing Phase I-III trials, including start-up activities; familiar with ICH-GCP, FDA, EMA regulations; proven leadership of global, multi-regional trials, especially in Asia-Pacific is preferred. Skills: strong leadership, organizational, and communication skills; problem-solving mindset; ability to manage multiple complex projects; collaborative, adaptable, and detail-oriented. High-Value: experience with biologics or small molecules in clinical development stages, global trial oversight, and cross-cultural team management. Work setup: hybrid with up to 20% travel.