Director, Clinical Development

About the Role

Alto Neuroscience is seeking a Director, Clinical Development to join our Clinical Trials team. This role plays a key part 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.

Responsibilities

• Serve as the medical expert overseeing the safety and medical aspects of clinical trials
• Ensure clinical trials are conducted in compliance with protocol, regulatory requirements, and ethical guidelines
• Review and determine patient eligibility for clinical trials
• Monitor trial progress to ensure participant safety, appropriate data collection, and overall study integrity
• Assess and review adverse events (AEs), serious adverse events (SAEs), and other medical issues
• Provide medical guidance for timely reporting, investigation, and management of AEs/SAEs
• Collaborate with clinical teams to determine causality, severity, and potential clinical implications of AEs/SAEs
• 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
• 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
• Ensure compliance with 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
• Work closely with clinical operations, data management, regulatory affairs, pharmacovigilance, and other departments
• Provide medical guidance and training to clinical site staff, investigators, and other relevant stakeholders
• Participate in safety monitoring activities and provide medical input into risk management strategies
• Assess and contribute to the development of risk management plans, and escalate safety concerns as needed
• 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

Qualifications

• Medical degree (MD, DO, NP, PA, PharmD or equivalent) required
• Board certification in relevant medical specialties (e.g., psychiatry) preferred
• Minimum of 3-5 years of clinical or medical experience, with at least 2 years in a medical monitor or clinical research-related role
• Experience in clinical trial design, management, and safety monitoring required
• Familiarity with regulatory guidelines and industry standards, such as ICH-GCP, FDA, and EMA requirements

Skills

• Strong ethical standards and commitment to patient safety
• Critical thinking and hands-on problem-solving skills
• High level of detail orientation and ability to work independently
• Proficiency in clinical trial software, database management systems, and safety reporting tools
• Ability to manage multiple priorities in a fast-paced environment

Pay & Schedule

• Salary range: $215,000 - $255,000 depending on qualifications and experience level
• Onsite in Mountain View, CA or remote considered
• Approximately 20% travel required