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Praxis Precision Medicines

Clinical-stage biopharma developing CNS therapies

Clinical Medical Monitor

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeRemote in USA$260k - $335k /yr

About the Job

Requirements

  • An MD or equivalent medical degree is required.
  • Clinical trial experience with responsibility for medical monitoring, clinical safety, or related medical oversight is required.
  • Strong clinical judgment and demonstrated ability to assess adverse events and serious adverse events consistently and rigorously are required.
  • Experience responding to investigator and site medical questions and making timely decisions when information is incomplete is required.
  • Ability to review clinical data, recognize meaningful patterns or potential safety signals, and determine when action or additional surveillance is needed is required.
  • Working knowledge of Good Clinical Practice, clinical trial safety reporting requirements, and documentation standards is required.

Responsibilities

  • Provide timely medical guidance for assigned studies, including eligibility, dosing, protocol requirements, safety events, and other study-related medical questions.
  • Review adverse events and serious adverse events, assessing causality, severity, expectedness, clinical significance, and potential implications for patients and the program.
  • Respond promptly and consistently to investigator and site medical questions, balancing patient safety, protocol requirements, and sound clinical judgment.
  • Review patient-level and aggregate clinical and safety data to identify trends, inconsistencies, emerging signals, and areas requiring follow-up.
  • Ensure medical monitoring, safety assessment, escalation, and documentation meet applicable regulatory requirements, Good Clinical Practice standards, and study protocols.
  • Work closely with clinical development, clinical operations, safety/pharmacovigilance, biostatistics, data management, and regulatory colleagues to resolve issues and support high-quality study execution.
  • Bring an independent medical perspective to decisions, challenge assumptions when warranted, and determine what to escalate and when.

Desired Qualifications

  • Central nervous system or relevant therapeutic-area experience is preferred.

About the Company

Praxis Precision Medicines

Clinical-stage biopharma developing CNS therapies

Praxis Precision Medicines develops therapies for central nervous system disorders driven by neuronal imbalance, with a focus on genetic epilepsies. Its treatments target restoring balance in CNS networks and are advanced in clinical development to address unmet medical needs. The company differentiates itself by using patient-guided development and forming partnerships to align with real patient needs. Its goal is to bring effective CNS therapies to patients and caregivers by advancing through clinical development toward potential commercialization and collaborations.

Company size
201-500
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2015

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