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Salary: USD 215,000 - 255,000 / annual
Alto Neuroscience is seeking a Director, Clinical Development to lead medical oversight and expertise throughout clinical trials for precision psychiatry therapeutics. This role is central to clinical research and drug development, ensuring patient safety, regulatory compliance, and scientific integrity across all trial phases.
Key Responsibilities:
Clinical Trial Oversight: Serve as the medical expert overseeing safety and medical aspects of clinical trials. Ensure trials are conducted in compliance with protocol, regulatory requirements, and ethical guidelines. Review and determine patient eligibility. Monitor trial progress to ensure participant safety, appropriate data collection, and study integrity.
Adverse Event Management: 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 clinical implications.
Protocol Development and Review: Collaborate with study teams to design, review, and update clinical trial protocols, informed consent forms, and study-related documents. Ensure protocols reflect 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. Interpret clinical trial results and provide medical insights to stakeholders, including study teams, sponsors, and regulatory authorities.
Regulatory Compliance and Reporting: Ensure compliance with FDA, EMA, and other regulatory authorities. Prepare and review safety reports, including periodic safety updates (PSURs) and expedited reporting of AEs/SAEs.
Cross-Functional Collaboration: Work closely with clinical operations, data management, regulatory affairs, pharmacovigilance, and other departments. Provide medical guidance and training to clinical site staff, investigators, and stakeholders.
Safety Review and Risk Management: Participate in safety monitoring activities and provide medical input into risk management strategies. Assess and contribute to development of risk management plans; escalate safety concerns as needed.
Stakeholder Communication: Communicate medical concerns and safety information to sponsors, clinical teams, and external stakeholders. Participate in investigator meetings and provide medical insights into study design, protocol amendments, and safety concerns.
Approximately 20% travel required.
Requirements:
Education: Medical degree (MD, DO, NP, PA, or PharmD) required. Board certification in relevant medical specialties (e.g., psychiatry) preferred.
Experience: Minimum 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.
Required 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.
