Senior Manager, Monitoring Quality Oversight (Clinical Operations)

Location: South San Francisco, CA, or San Diego, CA; onsite four days per week with work-from-home flexibility. Travel of up to 80% may be required.

Salary: $168,000–$208,000 per year.

Company

hirify.global is a precision medicine oncology company developing targeted small-molecule and antibody-drug conjugate therapies for molecularly defined solid tumors.

What you will do

• Conduct monitoring quality oversight visits across North American clinical studies.
• Develop study-specific monitoring quality oversight plans and review CRO monitoring plans.
• Evaluate monitoring reports, identify trends and compliance issues, and implement corrective and preventive action plans.
• Provide guidance to clinical operations teams, CRO monitors, and service providers on protocol deviations, adverse events, data quality, and monitoring practices.
• Perform risk assessments, maintain monitoring metrics, improve oversight processes, and support SOP development.
• Present oversight findings to senior management and coordinate with quality assurance teams for audits and inspections.

Requirements

• Bachelor’s degree in life science or an equivalent combination of education, training, and relevant experience.
• At least 6 years of relevant biotech or pharmaceutical industry experience, including at least 3 years focused on monitoring oversight.
• At least 3 years of oncology experience.
• Clinical Operations experience and thorough knowledge of GCP, relevant ICH standards, FDA/EMA guidelines, and clinical trial processes.
• Experience managing CRO relationships and overseeing monitoring activities, with strong analytical, organizational, communication, and problem-solving skills.
• Proficiency with Microsoft Office, clinical trial management systems, and data management tools; Smartsheet experience is a plus.

Culture & Benefits

• Collaborative, inclusive, data-driven environment focused on advancing precision oncology therapies.
• Medical, dental, and vision coverage fully paid for employees and 90% paid for dependents.
• 401(k), employee stock purchase plan, wellness programs, and potential merit increases, short-term incentives, and stock options.
• Employees working in company facilities must be fully vaccinated against COVID-19, subject to applicable accommodations and legal requirements.