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Department: | Development |
Location: | Mountain View, CA |
PRIMARY ROLE
Alto Neuroscience is seeking a Medical Monitor to add to our Clinical Trials team.The Medical Monitor 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, or PA), 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.
DUTIES & RESPONSIBILITIES
Clinical Trial Oversight & Protocol Development:
Oversee safety and medical aspects of trials, ensuring compliance with protocol, regulatory standards, and ethical guidelines
Review patient eligibility and monitor trial progress for safety, data accuracy, and integrity
Collaborate on designing and updating trial protocols and informed consent forms, ensuring alignment with scientific evidence and safety standards
Adverse Event & Safety Management:
Assess and review adverse events (AEs/SAEs), providing guidance on timely reporting, investigation, and management
Collaborate with teams to evaluate causality and clinical implications of AEs/SAEs
Participate in safety monitoring and contribute medical input to risk management plans
Medical Review, Data Analysis & Regulatory Compliance:
Analyze clinical data for safety and efficacy trends, offering medical insights and recommendations to stakeholders
Ensure compliance with regulatory bodies (FDA, EMA), preparing safety reports and expedited AE/SAE reports
Cross-Functional Collaboration & Stakeholder Communication:
Work closely with clinical operations, data management, regulatory affairs, and other departments to ensure trial success
Provide medical guidance to site staff and investigators and communicate safety concerns to sponsors and stakeholders
LOCATION
Remote or on-site in Mountain View office
SALARY
$215-255k (Depending on qualifications and experience level)
QUALIFICATIONS
Education:
Medical degree (MD, DO, NP, PA or equivalent) required
Board certification in relevant medical specialties (e.g., internal medicine, pharmacology) preferred
Advanced clinical research certifications (e.g., CCRP, CCRA) are a plus
Experience:
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
Required Skills/Abilities:
Willingness and ability to travel as needed, approximately 20% of the time
Strong ethical standards and commitment to patient safety
Critical thinking and 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
Alto Neuroscience is an equal-opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.
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