Clinical Medical Monitor

The role

You will provide medical oversight for assigned clinical programs. This includes supporting investigators on eligibility, dosing, and safety events while reviewing clinical and safety data.

What you will do

• Provide timely medical guidance for assigned studies regarding eligibility, dosing, and protocol requirements
• Review AEs and SAEs, assessing causality, severity, and clinical significance
• Respond to investigator and site medical questions
• Review patient-level and aggregate clinical and safety data to identify trends and signals
• Ensure medical monitoring and safety assessment meet regulatory requirements and GCP standards
• Partner with clinical development, operations, safety, biostatistics, data management, and regulatory colleagues
• Apply independent medical judgment to decisions and escalations

Required qualifications

• MD or equivalent medical degree
• Clinical trial experience with responsibility for medical monitoring, clinical safety, or related medical oversight
• Strong clinical judgment to assess AEs and SAEs
• Experience responding to investigator and site medical questions
• Ability to review clinical data and recognize safety signals
• Working knowledge of GCP, clinical trial safety reporting requirements, and documentation standards

Nice to have

• CNS or relevant therapeutic area experience

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance
• AD&D
• Disability benefits
• Voluntary plans
• 401(k) matching up to 6%
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Flexible wellness benefit
• Generous PTO
• Paid holidays and company-wide shutdowns

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company focuses on developing high impact medicines for patients and families affected by complex brain disorders.