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Alto Neuroscience

AI-driven precision psychiatric drug development

Senior Manager - Clinical Operations

Clinical Research OperationsUpdated on Nov 15
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.
  • Strong working knowledge of ICH-GCP, FDA and EMA regulations, and the clinical trial lifecycle.
  • Demonstrated 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.
  • 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, 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, including Trial Master File 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 full-time-equivalent planning in partnership with Clinical Operations leadership.
  • Ensure team members follow ICH-GCP, standard operating procedures, and applicable regulatory requirements across assigned trials.
  • Review and approve key study deliverables, including monitoring plans, Trial Master File completeness, and site management plans, as appropriate to level.
  • Provide direct, hands-on guidance on site selection, initiation, monitoring, and close-out, performed in-house by the team's Clinical Research Associates and Clinical Trial Managers rather than a contract research organization.
  • 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 corrective and preventive action 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.
  • Directly manage, coach, and develop Clinical Operations staff across Clinical Trial Associate, Clinical Research Associate, Clinical Trial Manager, and Clinical Project Manager 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 is a plus.

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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