Director, Clinical Operations & People Leadership

Alto Neuroscience, Inc.

Mountain View (CA)

Remote

USD 170,000 - 185,000

Full time

2 days ago
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Job summary

Alto Neuroscience, Inc. is seeking an Associate Director of Clinical Operations to lead a dedicated team of CTA, CRA, CTM, and CPM professionals. This role drives site management, trial execution, and staff development within an in-house model, ensuring quality and regulatory adherence.

You will oversee staffing, capacity planning, and cross-functional collaboration with development, regulatory, and data teams. A strong background in ICH-GCP and inspections is essential, with travel as needed.

Qualifications

  • 10+ years of hands-on clinical trial experience across multiple Clinical Operations roles.
  • 3+ years of direct people management experience.
  • In-house site monitoring, initiation, and trial execution.
  • Strong working knowledge of ICH-GCP, FDA/EMA regulations, and lifecycle of trials.
  • Demonstrated experience managing and developing Clinical Operations staff.
  • Experience with inspections, audits, and CAPA follow-up.

Responsibilities

  • Directly manage, coach, and develop a team of clinical staff across CTA, CRA, CTM, and CPM levels.
  • Ensure adherence to ICH-GCP, SOPs, and regulatory requirements across trials.
  • Provide hands-on guidance on site selection, initiation, monitoring, and close-out.
  • Escalate issues and support QA with audit readiness and CAPA closure.
  • Collaborate cross-functionally with Clinical Development, Regulatory, Biostatistics, and Data Management.

Skills

Hands-on clinical trials across ops
People management & coaching
In-house trial execution
ICH-GCP FDA/EMA knowledge
Site monitoring & management
Audit readiness & CAPA

Education

Bachelor's degree in life sciences/nursing/related

Job description

Alto Neuroscience, Inc. is seeking an Associate Director of Clinical Operations to lead a dedicated team of CTA, CRA, CTM, and CPM professionals. This role drives site management, trial execution, and staff development within an in-house model, ensuring quality and regulatory adherence.

You will oversee staffing, capacity planning, and cross-functional collaboration with development, regulatory, and data teams. A strong background in ICH-GCP and inspections is essential, with travel as needed.

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