Director/Senior Medical Sciences (Medical Monitoring)

Role Summary

Director/Senior Medical Sciences (Medical Monitoring) responsible for providing input into the design and conduct of clinical trials, reviewing and generating key study documents, assessing and interpreting safety data, and contributing to training of investigators and study teams.

Responsibilities

• Be readily available to advise on assigned clinical trial related medical questions or problems during the conduct of the trial.
• Review and analyze participant eligibility per inclusion/exclusion requirements of a clinical trial.
• Review all adverse events to identify trends or risks; review serious adverse events (SAEs), including narrative review, causality assessment, and regulatory reporting.
• Provide review of study protocols and ongoing medical oversight of trials to ensure safety concerns are identified and addressed appropriately.
• Ensure SAE activities are conducted in accordance with applicable SOPs and regulations.
• Consult with internal and external stakeholders in the development of trial design and conduct, including drafting protocols and amendments.
• Develop and/or review operational, medical monitoring, and safety plans for studies.
• Lead and/or participate in scientific and medical training for team members, clients, investigators, and site staff related to assigned studies.
• Generate safety-related documents such as medical monitoring reports and safety databases to ensure SAE reporting is current and complete.
• Write and/or review Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.

Qualifications

• Must have an MD or equivalent with Board Certification in Ophthalmology (preferred) or subspecialty and a current California medical license.
• Minimum of 5-7 years direct experience in medical monitoring and/or pharmacovigilance and/or drug safety in a pharmaceutical, clinical trial environment or CRO.
• Proficiency with ICH/GCP guidelines and other applicable regulatory rules and guidelines, as well as medical terminology, clinical trials, and clinical research.

Skills

• Medical monitoring and pharmacovigilance expertise
• Safety data analysis and SAE management
• Regulatory knowledge (ICH/GCP, etc.)
• Scientific and medical training capability

Education

• MD or equivalent; Board Certification in Ophthalmology (preferred)

Additional Requirements

• California medical license (required)