Senior Director, Clinical Operations (AI Biotech)

Location: Onsite at hirify.global’s headquarters in South San Francisco, California, United States; approximately 20% travel for investigator and site engagement, vendor governance, and scientific meetings.

Base salary: $250,000–$311,000 annually, plus bonus and equity.

Company

Biotech startup using generative AI and foundation models for biology and disease to design protein and antibody therapeutics and improve drug discovery and development.

What you will do

• Establish and lead the clinical operations function, including its operating model, governance, systems, processes, metrics, budget, and resource plan.
• Lead end-to-end delivery of clinical studies from start-up through database lock and clinical study report, managing timelines, budgets, enrollment, quality, and risk.
• Hire, develop, and manage the clinical operations team across trial management, study start-up, site management, and clinical supply coordination.
• Develop country and site strategies for biomarker-defined and narrowly defined patient populations, including feasibility, recruitment, retention, monitoring, and contingency planning.
• Lead CRO, laboratory, biomarker, imaging, IRT, eCOA, and other specialist vendor selection, contracting, governance, budgets, and performance management.
• Implement clinical systems and data workflows across EDC, CTMS, eTMF, IRT, and eCOA, applying analytics, automation, and AI where they improve trial execution.

Requirements

• 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, development, and performance management.
• Experience leading early-phase and first-in-human studies, including accountability for at least one study from start-up through database lock.
• Oncology clinical operations experience with biomarker-defined or otherwise narrowly defined patient populations.
• Strong knowledge of ICH GCP and global regulations, plus experience with clinical operations infrastructure, SOPs, inspection readiness, CRO management, and executive communication.

Nice to have

• Experience establishing clinical operations at a company conducting its first clinical trials.
• Experience with protein or antibody therapeutics, precision medicine, biomarker-enriched studies, and global multi-region study start-up.
• Experience applying analytics, automation, AI or machine learning, digital endpoints, or model-informed approaches in clinical development.
• Experience implementing or migrating EDC, CTMS, eTMF, IRT, or eCOA systems.
• Experience supporting BIMO or other health authority inspections.

Culture & Benefits

• Open, flexible, and friendly work environment.
• Competitive compensation package including base salary, bonus, and equity.
• Benefits package available to all applicants.
• Opportunity to build a clinical operations function and develop a long-term career in an AI-focused biotech startup.