Primary Role

The Medical Director will be responsible for the clinical, medical, and safety aspects of clinical studies of CNS compounds (Phase 1-3) under the supervision of the Chief Medical Officer and other staff. Specifically, the Medical Director.

Duties And Responsibilities

• Oversees the medical, clinical, psychiatric, and overall conduct of clinical trials
• Is responsible for answering questions around eligibility and medical/psychiatric issues from the site
• Reviews safety listings on a regular basis. With clinical operations, monitors site conduct of the study, ensuring high quality of the clinical data and that the studies are conducted according to GCP
• Contribute to the design (protocol), start-up including review of clinical study documents, execution, analysis and communication of the clinical studies
• Is responsible for data review in conjunction with other clinical team members prior to database locks
• Is responsible for various activities associated with safety monitoring working closely with the pharmacovigilance provider and will provide clinical support for various regulatory documents, including the Investigator Brochure, the Informed Consent form, Safety Management Plan
• Collaborates with regulatory on timing and content of regulatory filings, serving as the clinical subject matter expert including IND submissions and FDA annual reports
• Interprets, reports, and prepares oral and written results of product research, in concert with senior staff, in preparation for internal and external reviews
• Provides input to the Clinical Development Plan (CDP), review and analysis of clinical trial data, provides input and review of clinical study reports, and supports preparation of publications.
• Collaborates with other functions
• Reviews medical literature and related new technologies
  
  

LOCATION

Remote or in-office

SALARY RANGE

$260,000-$300,000 per year

Qualifications

• MD or other clinical degree such as NP/PA. PhD in psychology may be considered with appropriate experience with medical monitoring
• A minimum of 2 years of experience working in clinical trials for pharmaceutical/biotech
• Proven ability to interpret, discuss, and present efficacy and safety data
• Experience in Psychiatry, Neurology, or Neuroscience is preferred
• Clinical research operational knowledge, strong project planning/management and excellent communication skills is preferred
• Experience interacting with the US FDA preferred
• Home or Office based with the ability to work modified US West Coast hours and travel as needed for the position
  
  

Alto Neuroscience, Inc. 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