Director, Clinical Development

Alto Neuroscience, Inc.; Mountain View (CA); Hybrid; USD 215.000 - 255.000; Vollzeit

Zusammenfassung

Alto Neuroscience, Inc. is seeking a Director of Clinical Development to provide medical oversight across clinical trials, ensuring patient safety, protocol adherence, and regulatory compliance.

The role requires an MD/DO/NP/PA/PharmD or equivalent, strong clinical knowledge, and excellent communication skills to collaborate with clinical operations, regulatory affairs, and external sites for successful study execution.

Qualifikationen

• 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.

Aufgaben

• Serve as the medical expert overseeing the 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 for the clinical trial.
• Monitor progress of trials to ensure participant safety, data collection, and study integrity.
• Assess and review adverse events (AEs/SAEs) and provide medical guidance for reporting and management.
• Collaborate with study teams to design and update protocols and informed consent forms.
• Review clinical data to assess safety and efficacy trends and provide medical insights to stakeholders.
• Ensure regulatory compliance and reporting to agencies such as FDA and EMA.
• Collaborate with cross-functional teams to support trial success and provide medical guidance.

Kenntnisse

Strong ethical standards

Critical thinking

Detail orientation

Clinical trial software proficiency

Multi-priority management

Ausbildung

Medical degree (MD/DO/NP/PA/PharmD)

Board certification (psychiatry preferred)

Jobbeschreibung

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.

Primary Role

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.

What you'll do

• 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.

Location

Onsite in Mountain View, CA or will consider remote

Salary Range

$215,000 - $255,000

Travel Required

Approximately 20% travel

Qualifications

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.
• Education:
• Medical degree (MD, DO, NP, PA, PharmD or equivalent) required.
• Board certification in relevant medical specialties (e.g., psychiatry) preferred.
• 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.

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.