Senior Vice President, Clinical Development (Biotech)

Location: San Diego, California, United States; office-based work environment with approximately 20% domestic and international travel.

Salary: $306,000–$459,000 annually, plus a 35% bonus, 10% 401(k) contribution, options, and RSUs.

What you will do

• Set clinical development strategy for approved products and programs at all stages of development.
• Lead the design, planning, and execution of clinical trials for assigned therapeutic areas.
• Direct the Clinical Development team and collaborate with Clinical Operations, Biostatistics, Regulatory, Data Science, Research, Commercial, and Business Development functions.
• Oversee clinical investigators, vendors, monitoring activities, study data review, safety monitoring, and audit readiness.
• Prepare and review clinical sections of investigator brochures, INDs, NDAs, BLAs, FDA meeting packages, protocols, safety plans, and other regulatory documents.
• Manage clinical project budgets, resources, schedules, milestones, risks, and strategic partnerships.

Requirements

• MD and US medical license required.
• 15+ years of clinical drug development experience involving novel biologics.
• Expertise in preclinical, translational, and early clinical development.
• Strong understanding of clinical protocols, FDA requirements, Good Clinical Practices, regulatory processes, and pharmaceutical clinical development.
• Demonstrated program leadership, therapeutic-area strategy, cross-functional collaboration, and team management experience.
• Knowledge of the mechanistic basis of human inflammatory disorders and the commercial aspects of pharmaceutical development.

Culture & Benefits

• Leadership role in a cross-functional, matrix-based clinical development environment.
• Opportunity to shape clinical strategy for novel antibody programs and therapeutic indications.
• 401(k) contribution, options, and RSUs.
• Annual performance bonus targeted at 35%.
• Approximately 20% domestic and international travel.