Senior Manager / Associate Director, Clinical Operations at Alto Neuroscience in Mountain View, CA

Job description

• The Senior Manager/Associate Director, Clinical Operations provides line management and functional oversight for a team of clinical trial staff spanning Clinical Trial Associate (CTA), Clinical Research Associate (CRA), Clinical Trial Manager (CTM), and Clinical Project Manager (CPM) levels. Trials are run in-house rather than outsourced to a CRO, so this role and its team hold direct, hands-on responsibility for site management, monitoring, and trial execution rather than oversight of a CRO's delivery. This role is responsible for staff development, workload/resource allocation across assigned studies or programs, and ensuring consistent quality and process adherence across the team, while individual contributors retain day-to-day accountability for their assigned trials.

Responsibilities

• People Management
• Directly manage, coach, and develop a team of 6–12 clinical staff across CTA, CRA, CTM, and CPM levels
• Conduct performance reviews, goal setting, and career development planning tailored to each direct report's role and level
• Lead recruitment, onboarding, and training for new team members
• Identify training needs and coordinate role-specific development (e.g., TMF management for CTAs, site monitoring for CRAs, vendor oversight for CTMs, cross-functional leadership for CPMs)
• Resource & Workload Management
• Allocate staff across studies based on trial phase, complexity, and enrollment status
• Monitor team capacity and escalate resourcing gaps or overallocation to the Director/Senior Director
• Support study budgeting and FTE planning in partnership with Clinical Operations leadership
• Operational & Quality Oversight
• Ensure team members follow ICH-GCP, SOPs, and applicable regulatory requirements across assigned trials
• Review and approve key study deliverables (monitoring plans, TMF completeness, site management plans) as appropriate to level
• Provide direct, hands-on guidance on site selection, initiation, monitoring, and close-out — activities performed in-house by the team's CRAs and CTMs rather than a CRO
• Serve as an escalation point for site-level or protocol-execution issues that direct reports cannot resolve independently
• Partner with QA on audit/inspection readiness and CAPA follow-up for the team's studies
• Cross-Functional Collaboration
• Represent Clinical Operations staffing and capacity needs in program-level planning meetings
• Partner with Clinical Development, Regulatory, Biostatistics, and Data Management leads to align trial execution with program timelines
• Provide input to senior leadership on process improvements and standardization across trials

Requirements

• 10+ years of hands-on clinical trial experience across multiple Clinical Operations roles, including CTA, CRA, CTM, and/or CPM experience.
• 3+ years of direct people management experience.
• Direct experience with site monitoring, site management, and clinical trial execution in an in-house operating model.
• Strong working knowledge of ICH-GCP, FDA/EMA regulations, and the clinical trial lifecycle.
• Demonstrated experience managing and developing Clinical Operations staff across varying levels of seniority.
• Strong organizational, communication, and problem-solving skills, with the ability to manage competing priorities across multiple studies.
• Experience with inspection readiness, audits, and CAPA follow-up.
• Experience supporting multiple clinical programs or studies simultaneously.
• Directly manages, coaches, and develops Clinical Operations staff across CTA, CRA, CTM, and CPM levels, including performance management, goal setting, career development, and workload allocation.
• Bachelor's degree in life sciences, nursing, or related field (advanced degree a plus)
• Experience building or improving Clinical Operations processes, tools, and ways of working in a growing biotech environment.

Skills

Required

• Clinical trial management
• Site monitoring
• Site management
• People management
• ICH-GCP knowledge
• FDA/EMA regulations knowledge
• Inspection readiness
• Audit management
• CAPA follow-up
• Organizational skills
• Communication skills
• Problem-solving skills

Preferred

• Process improvement
• Tool development
• Biotech environment experience

Benefits

• $170,000 - $185,000
• *depending on qualifications and experience level