Provide medical oversight for interventional clinical studies, serving as the main medical contact for site eligibility questions, safety reviews, and protocol guidance. The work centers on adverse event assessment, benefit-risk evaluation, and monitoring psychiatric safety considerations in CNS trials, including suicidality measures and depression-focused studies. The role also supports protocol and safety-document review, signal review, and preparation for safety committees and DSMBs across US and UK sites.
Key Responsibilities
- Provide medical oversight of study conduct and respond to site medical and eligibility questions.
- Review eligibility, protocol deviations, and safety data throughout the study.
- Assess adverse events and serious adverse events, including causality and expectedness, with pharmacovigilance support.
- Contribute to safety monitoring, signal review, and preparation for DSMB and safety-committee meetings.
- Advise on suicidality monitoring and psychiatric safety considerations for CNS trials.
- Review protocols, investigator brochures, and safety documents with an inspection-readiness focus.
- Support benefit-risk assessment across ongoing studies.
Required
- MD or international equivalent.
- Active or prior clinical experience.
- Clinical-trial medical monitoring experience in interventional studies.
- Strong knowledge of ICH-GCP and drug safety.
- Ability to respond quickly to time-sensitive medical questions.
- Availability for responsive medical coverage across US and UK sites, including urgent queries.
Preferred
- Psychiatry or CNS background.
- Experience with depression or treatment-resistant depression trials.
- Familiarity with psychiatric rating scales.
- Experience with placebo-response considerations.