This physician role provides medical monitoring and strategic oversight for ophthalmology clinical trials, with a focus on safety, efficacy, and study-level medical decision-making. Day-to-day work includes protocol input, feasibility assessment, regulatory review, and engagement with investigators, KOLs, reading centers, and safety committees. The role may also support other therapeutic areas and contribute to business development, internal training, and broader clinical research operations.
Key Responsibilities
- Provide medical monitoring for assigned ophthalmology studies, including review of safety and efficacy data.
- Conduct real-time assessment of adverse events, serious adverse events, protocol deviations, and ophthalmology-specific safety events.
- Review safety deliverables such as SAE narratives, safety listings, MedDRA/WHO Drug coding, IND/IDE reports, CIOMS reports, and DSURs.
- Provide medical input for protocols, including safety criteria, inclusion/exclusion criteria, ophthalmic assessments, imaging requirements, and halting rules.
- Review and contribute to clinical documents such as investigator brochures, informed consent forms, CRFs, imaging manuals, and clinical study reports.
- Participate in safety oversight committees, sponsor meetings, investigator meetings, and regulatory interactions.
- Coordinate with Safety Monitors, site investigators, reading centers, imaging vendors, and external ophthalmology experts.
- Conduct training for internal teams on ophthalmic diseases, assessments, imaging, and trial-specific medical topics.
Required
- Medical Doctor degree, such as MD, MBBS, MBBCh, or equivalent.
- At least 8 years of working experience.
- Experience in clinical practice and/or pharmaceutical medicine, clinical research, pharmacovigilance, medical affairs, or regulatory work.
- Strong clinical judgment and ability to communicate complex clinical issues clearly.
- Experience with regulatory submissions.
- Fluency in English.
Preferred
- Clinical medicine practice experience.
- Experience in safety monitoring or serious adverse event reporting.
- Training or experience in clinical trial data collection.
- Ability to work effectively on cross-functional teams.
Benefits & Perks
- Work from home anywhere in the US.
- Flexible approved time off.
- Tuition reimbursement.
- 401(k) retirement plan.
- Maternal/paternal leave.
- Casual dress code and work environment.
- Opportunities for volunteerism through an employee community engagement program.