Director/Sr. Director, Clinical Operations

Role Overview

• Lead the end-to-end execution of clinical trials from study start-up through close-out
• Translate clinical development strategy into actionable operational plans, timelines, and budgets
• Own study-level delivery, ensuring trials are conducted on time, within budget, and in compliance
• Identify risks early and drive mitigation strategies to maintain program momentum
• Lead day-to-day oversight of CROs and external vendors, ensuring performance, quality, and accountability
• Define and track KPIs and deliverables, escalating issues as needed
• Partner with VP and cross-functional stakeholders on vendor selection and governance
• Act as the primary escalation point for operational challenges
• Drive alignment across Clinical Development, Translational & Research, Regulatory, and CMC / Manufacturing
• Ensure seamless communication of timelines, risks, and decisions across teams
• Build and implement study-level processes, tools, and tracking mechanisms
• Contribute to the development of broader clinical operations infrastructure in partnership with the VP
• Ensure study execution aligns with ICH-GCP, regulatory requirements, and internal SOPs
• Oversee TMF quality and completeness at the study level, ensuring inspection readiness
• Support audits and inspections in collaboration with Quality and VP Clinical Operations
• Provide direction and mentorship to clinical operations staff (e.g., CTAs, CTMs) as applicable
• Foster accountability, prioritization, and strong execution across the study team
• Contribute to hiring and scaling of the clinical operations function

Requirements

• Bachelor’s degree in life sciences or related field; advanced degree preferred with 10+ years (Director) / 12+ years (Senior Director) in clinical operations
• Demonstrated experience leading early-phase oncology clinical trials (Phase I/II)
• Experience in hematological malignancies and cell and gene therapy strongly preferred
• Proven success managing CROs and cross-functional clinical programs
• Deep understanding of clinical trial execution, ICH-GCP, and global regulatory requirements
• Experience with clinical systems (e.g., CTMS, eTMF, EDC)
• Strong operational planning and risk management capabilities
• Experience managing study budgets and timelines
• Strong execution mindset with end-to-end ownership of deliverables
• Ability to operate effectively in a lean, ambiguous, and fast-moving environment
• Skilled at balancing strategic thinking with hands-on execution
• Excellent communication and cross-functional influence
• Proactive problem solver with a focus on delivering results

Tech Stack

• Google Cloud Platform

Benefits

• Flexible Time Off
• flexible scheduling that aligns with your needs and our objectives
• a competitive benefits package (health, commuter, and more)
• free parking
• state-of-the-art gym
• food hall
• collaborative, inclusive team that invests in your development