Senior Director, Clinical Operations

What you'll do

• Build the clinical operations operating model, team, processes, systems, governance, and budget.
• Lead study delivery from start-up through database lock and clinical study report, managing timelines, enrollment, cost, quality, and risk.
• Oversee CROs and specialist vendors, ensure compliance and inspection readiness, and partner with science and data teams on clinical data, systems, analytics, and AI-enabled execution.

What they ask for

• Bachelor’s degree in a scientific or health-related discipline.
• At least 15 years of clinical operations experience in biotechnology, pharmaceuticals, or a CRO, including end-to-end study leadership.
• At least 7 years of direct line management experience, including hiring, staff development, and performance management.
• Experience leading early-phase studies including first-in-human, accountability for at least one study from start-up through database lock, and oncology studies in biomarker-defined or narrowly defined populations.

Nice to have

• Experience at a company conducting its first clinical trials or establishing a clinical operations function.
• Experience with protein or antibody therapeutics, precision medicine or biomarker-enriched studies, global studies, clinical systems implementation, AI or analytics, or health authority inspections.

Pay

$250,000 - $311,000 annually (base salary)

Tools

ICH GCP, EDC, CTMS, eTMF, IRT, eCOA

AI focus

Apply analytics, automation, and AI-enabled tools to improve trial feasibility, site selection, enrollment forecasting, monitoring, and risk identification; evaluate model-informed design and digital endpoints for practical value.