Job Description

Job Responsibilities:

• Under the direction of the Global Medical Lead (GML), responsible for providing medical monitoring and/or study start up activities for 1-3 programs in Ophthalmology.
• Be available to advise on assigned clinical trial(s) related medical questions or problems during the trial, including 24/7 emergency coverage for safety-related matters.
• Aligns with the GML, reviews and analyzes the eligibility of participants per inclusion/exclusion requirements of a clinical trial.
• Reviews all adverse events to look for trends or risks, reviews all serious adverse events (SAEs), including review of the narrative, investigators’ assessment on causality, and applicable regulatory reporting, with close collaboration with the study’s Product Responsible Person (PRP).
• Provides review of study protocols and ongoing medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
• Ensures activities related to Severe Adverse Events (SAEs) are conducted in accordance with applicable SOPs and regulations.
• Includes writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
• Develops and/or reviews operational, medical monitoring, and safety plans for studies.
• Leads and/or participates in scientific and medical training of other team members and external clients, investigators, and other site staff as it pertains to assigned studies.
• Generates safety-related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.

Skills:

• Excellent scientific writing skills.
• Ability to read and analyze ocular images.
• Experience analyzing, synthesizing, and communicating clinical trial data.
• Proficiency with ICH/GCP guidelines and other applicable regulatory rules and guidelines.
• Knowledge of medical terminology, drug development, clinical trials, and clinical research.
• Willingness to work across different ophthalmic indications.
• Prior experience working at another Biotechnology, Pharmaceutical company or CRO is preferred.
• Experience working in cell or gene therapy drug development is preferred.

Education/Experience:

• Medical Degree (or Medically Qualified) with completion of residency in Ophthalmology with active or prior Board Certification.
• Should have at least 8 years relevant experience in drug development in a biotech/pharmaceutical company or equivalent experience in an academic clinical research institute (NCI, NIH, Academic Research groups, etc) with at least 5 years working in clinical development.
• Experience in clinical development and medical monitoring of ophthalmology clinical trials.

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