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Salary: USD 170,000 - 185,000 / annual
Alto Neuroscience is seeking a Senior Manager/Associate Director of Clinical Operations to lead a team of 6–12 clinical staff (Clinical Trial Associates, Clinical Research Associates, Clinical Trial Managers, and Clinical Project Managers) in executing in-house clinical trials for precision psychiatry and neuroscience-based therapeutics.
In this role, you will provide direct line management and functional oversight of clinical operations staff. Unlike outsourced CRO models, Alto runs trials in-house, so you and your team hold hands-on responsibility for site management, monitoring, and trial execution.
Key responsibilities include:
**People Management:** Directly manage, coach, and develop a team across CTA, CRA, CTM, and CPM levels. Conduct performance reviews, goal setting, and career development planning. Lead recruitment, onboarding, and training. Identify and coordinate role-specific development needs (e.g., TMF management, site monitoring, vendor oversight, cross-functional leadership).
**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 senior leadership. Support study budgeting and FTE planning in partnership with Clinical Operations leadership.
**Operational & Quality Oversight:** Ensure team adherence to ICH-GCP, SOPs, and applicable regulatory requirements. Review and approve key study deliverables (monitoring plans, TMF completeness, site management plans). Provide direct, hands-on guidance on site selection, initiation, monitoring, and close-out. Serve as an escalation point for site-level or protocol-execution issues. Partner with QA on audit/inspection readiness and CAPA follow-up.
**Cross-Functional Collaboration:** Represent Clinical Operations staffing and capacity needs in program-level planning. Partner with Clinical Development, Regulatory, Biostatistics, and Data Management to align trial execution with program timelines. Provide input to senior leadership on process improvements and standardization.
Travel required: approximately 25–30%.
**Requirements:**
- 10+ years of hands-on clinical trial experience across multiple Clinical Operations roles (CTA, CRA, CTM, and/or CPM)
- 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; 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
- Bachelor's degree in life sciences, nursing, or related field (advanced degree a plus)
**Bonus Skills:**
- Experience building or improving Clinical Operations processes, tools, and ways of working in a growing biotech environment
