Director, Clinical Development
About The Position
Alto Neuroscience is seeking a Director, Clinical Development to join its Clinical Trials team. The role provides medical oversight and expertise throughout clinical trials, supporting patient safety, regulatory compliance, and scientific integrity. Responsibilities include confirming patient eligibility, assessing adverse events, interpreting trial data, and ensuring protocols are followed and regulatory requirements are met. The position collaborates with cross-functional teams and external sites to support successful clinical studies. The role may be onsite in Mountain View, California, or remote, and requires approximately 20% travel. The stated salary range is $215,000–$255,000, depending on qualifications and experience.
Requirements
- Medical degree (MD, DO, NP, PA, PharmD, or equivalent).
- At least 3–5 years of clinical or medical experience, including at least 2 years in a medical monitor or clinical research-related role.
- Experience in clinical trial design, management, and safety monitoring.
- Familiarity with regulatory guidelines and industry standards, such as ICH-GCP and FDA and EMA requirements.
- 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.
Nice To Haves
- Board certification in a relevant medical specialty, such as psychiatry.
Responsibilities
- Serve as the medical expert overseeing the safety and medical aspects of clinical trials.
- Ensure trials comply with protocols, regulatory requirements, and ethical guidelines.
- Review and determine patient eligibility for clinical trials.
- Monitor trial progress to support participant safety, appropriate data collection, and study integrity.
- Assess and review adverse events (AEs), serious adverse events (SAEs), and other study-related medical issues.
- Provide medical guidance for timely reporting, investigation, and management of AEs and SAEs.
- Collaborate with the clinical team to determine the causality, severity, and potential clinical implications of AEs and SAEs.
- Collaborate with study teams to design, review, and update clinical trial protocols, informed consent forms, and other study documents.
- Ensure protocols reflect current scientific evidence, patient safety considerations, and regulatory standards.
- Review and analyze clinical data for safety and efficacy trends and provide recommendations as needed.
- Interpret trial results and provide medical insights to stakeholders, including study teams, sponsors, and regulatory authorities.
- Ensure compliance with applicable regulatory bodies, including the FDA, EMA, and local authorities.
- Prepare and review safety reports, including periodic safety updates (PSURs) and expedited AE/SAE reports.
- Work 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 and provide medical input into risk management strategies.
- Assess and contribute to risk management plans, escalating safety concerns as needed.
- Communicate medical concerns and safety information to sponsors, clinical teams, and external stakeholders.
- Participate in investigator meetings and provide medical insights on study design, protocol amendments, and safety concerns.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
