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Alto Neuroscience

AI-driven precision psychiatric drug development

Associate Director - Clinical Operations: People & Functional Leadership

Clinical Research OperationsUpdated on Nov 14
Full-time$170k - $185k

About the Job

Requirements

  • At least 10 years of hands-on clinical trial experience across multiple Clinical Operations roles, including experience as a Clinical Trial Associate, Clinical Research Associate, Clinical Trial Manager, and/or Clinical Project Manager.
  • At least 3 years of direct people-management experience.
  • Direct experience with site monitoring, site management, and clinical trial execution in an in-house operating model.
  • Working knowledge of ICH-GCP, FDA and EMA regulations, and the clinical trial lifecycle.
  • Experience managing and developing Clinical Operations staff across varying levels of seniority.
  • 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.
  • A bachelor's degree in life sciences, nursing, or a related field.
  • Ability to sit for prolonged periods.
  • Ability to travel domestically and internationally.

Responsibilities

  • Directly manage, coach, and develop a team of 6–12 clinical staff across Clinical Trial Associate, Clinical Research Associate, Clinical Trial Manager, and Clinical Project Manager levels.
  • Conduct performance reviews, set goals, and plan career development 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, including TMF management for Clinical Trial Associates, site monitoring for Clinical Research Associates, vendor oversight for Clinical Trial Managers, and cross-functional leadership for Clinical Project Managers.
  • Allocate staff across studies based on trial phase, complexity, and enrollment status.
  • Monitor team capacity and escalate resourcing gaps or overallocation to the Director or Senior Director.
  • Support study budgeting and FTE planning in partnership with Clinical Operations leadership.
  • Ensure team members follow ICH-GCP, SOPs, and applicable regulatory requirements across assigned trials.
  • Review and approve key study deliverables, including monitoring plans, TMF completeness, and 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 Clinical Research Associates and Clinical Trial Managers rather than a CRO.
  • Serve as an escalation point for site-level or protocol-execution issues that direct reports cannot resolve independently.
  • Partner with Quality Assurance on audit and inspection readiness and CAPA follow-up for the team's studies.
  • 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.
  • Manage, coach, and develop Clinical Operations staff across CTA, CRA, CTM, and CPM levels, including performance management, goal setting, career development, and workload allocation.

Desired Qualifications

  • Experience building or improving Clinical Operations processes, tools, and ways of working in a growing biotech environment.
  • An advanced degree.

About the Company

Alto Neuroscience

AI-driven precision psychiatric drug development

Alto Neuroscience develops AI-guided precision psychiatric drugs. It uses brain biomarkers and clinical data to match patients to specific Alto drug candidates. The approach aims to improve outcomes with personalized, biology-based selection and relies on ongoing clinical trials and regulatory approval. The business model centers on developing and commercializing these drugs for the psychiatric market once approved.

Company size
51-200
Company stage
IPO
Headquarters
Los Altos, CA
Founded
2019

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