Clinical Trial Manager/Senior Clinical Trial Manager (Biotech)

Location: San Carlos, California; remote candidates may be considered. Must be permitted to work in the United States.

Base pay: $120,000–$170,000 per year, with the final range determined by work location, skills, experience, and education.

Company

Develops antibody therapeutics for oncology, autoimmune disorders, immunology, neurology, and other serious diseases through proprietary targeted myeloid engager and phagocytosis technologies.

What you will do

• Lead operational execution and oversight of clinical studies, including in-house US study management and international CRO and vendor oversight.
• Develop and maintain clinical protocols, amendments, informed consent forms, study plans, training materials, and related research documentation.
• Coordinate study team meetings, site feasibility, site start-up, CTA management, investigator relationships, and study team and vendor training.
• Oversee clinical systems and vendors covering laboratories, imaging, IRT, CRF design, database builds, and drug supply management.
• Manage enrollment, cohort screening, monitoring activities, data quality, data cleaning, study metrics, and clinical data deliverables.
• Collaborate with Medical Monitoring, Safety, Regulatory, Data Management, Statistics, CMC, Quality, and other cross-functional groups on study milestones and risk mitigation.

Requirements

• BS/BA in life sciences or a related field; an MS, PharmD, or PhD is preferred.
• 5–7 years of clinical operations experience in a biotechnology or pharmaceutical company.
• Experience leading international Phase I–III clinical trials, including multi-center studies, site management, CRO management, data collection, and protocol compliance.
• Experience with EDC, IRT, TMF, CTMS, and other clinical systems.
• Knowledge of US and global regulations and guidelines, including FDA, EMA, ICH, and GCP.
• Must be permitted to work in the United States; willingness to travel up to 30% is required.

Nice to have

• Experience in autoimmune diseases or dermatology.
• Experience with in-house, non-CRO study management.
• Advanced degree in a relevant discipline.

Culture & Benefits

• Competitive cash compensation and equity incentive awards.
• Employer-sponsored benefits.
• Hands-on work in a highly matrixed environment with internal and external cross-functional teams.
• Opportunities to develop scientific knowledge, managerial capabilities, and personal skills.
• Work on early-phase clinical studies under demanding timelines and multiple competing priorities.