Director, Clinical Development

At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics.

Alto Neuroscience is seeking a Director, Clinical Development to add to our Clinical Trials team. This role plays a key role in clinical research and drug development by providing essential medical oversight and expertise throughout clinical trials, ensuring patient safety, regulatory compliance, and scientific integrity. This position involves confirming patient eligibility, assessing adverse events, interpreting clinical trial data, and ensuring that protocols are followed, patients are properly cared for, and all regulatory requirements are met.

The role requires a professional degree (MD, DO, NP, PA or PharmD), strong medical knowledge, excellent communication skills, and the ability to collaborate effectively with cross-functional teams and external sites, including clinical operations, regulatory affairs, and other departments to support the successful execution of clinical studies.

• Clinical Trial Oversight:
• Serve as the medical expert overseeing the safety and medical aspects of clinical trials.
• Ensure that clinical trials are conducted in compliance with protocol, regulatory requirements, and ethical guidelines.
• Review and determine patient eligibility for the clinical trial.
• Monitor the progress of clinical trials to ensure participant safety, appropriate data collection, and overall study integrity.
• Adverse Event Management:
• Assess and review adverse events (AEs), serious adverse events (SAEs), and other medical issues related to the study.
• Provide medical guidance for the timely reporting, investigation, and management of AEs/SAEs.
• Collaborate with the clinical team to determine causality, severity, and potential clinical implications of AEs/SAEs.
• Protocol Development and Review:
• Collaborate with study teams to design, review, and update clinical trial protocols, informed consent forms, and other study-related documents.
• Ensure protocols reflect the latest scientific evidence, patient safety considerations, and regulatory standards.
• Medical Review of Clinical Data:
• Review and analyze clinical data to assess safety and efficacy trends, providing recommendations as necessary.
• Interpret clinical trial results and provide medical insights to stakeholders, including study teams, sponsors, and regulatory authorities.
• Regulatory Compliance and Reporting:
• Ensure compliance with applicable regulatory bodies, such as the FDA, EMA, and other local regulatory authorities.
• Prepare and review safety reports, including periodic safety updates (PSURs) and expedited reporting of AEs/SAEs.
• Collaboration with Cross-Functional Teams:
• Work closely with clinical operations, data management, regulatory affairs, pharmacovigilance, and other departments to ensure the success of the trial.
• Provide medical guidance and training to clinical site staff, investigators, and other relevant stakeholders.
• Safety Review and
  
  Risk Management:
  
  
• Participate in safety monitoring activities and provide medical input into risk management strategies.
• Assess and contribute to the development of risk management plans, and elevate safety concerns as needed.
• Stakeholder Communication:
• Communicate medical concerns and safety information to the sponsor, clinical teams, and external stakeholders.
• Participate in investigator meetings and provide medical insights into study design, protocol amendments, and safety concerns.

Onsite in Mountain View, CA or will consider remote

$215,000 - $255,000

Approximately 20% travel

• Strong ethical…