Ophthalmology Strategy and Medical Monitor

Ophthalmology Strategy and Medical Monitor

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us

Primary Purpose

The Ophthalmology Strategy and Medical Monitor provides strategic medical leadership and therapeutic-area expertise across ophthalmology clinical development programs. This role may also be asked to support other Therapeutic Areas as needed. This role has primary responsibility for medical monitoring of ophthalmology trials; scientific and clinical oversight of safety and efficacy data; and cross‑functional strategic input supporting protocol design, feasibility assessment, regulatory and medical strategy, and engagement with external ophthalmology experts. The role also supports business development activities and serves as an internal consultant for ophthalmic medical and scientific matters.

Strategic & Therapeutic‑Area Leadership

Partners with organizational leadership to shape medical and development strategy for ophthalmology programs, integrating clinical, regulatory, and commercial considerations.

Provides ophthalmology‑specific guidance during protocol concept development, feasibility assessments, country mix recommendations, competitive landscape reviews, and early scientific strategy.

Serves as internal clinical expert for retina, cornea, glaucoma, uveitis, infectious and inflammatory ophthalmic diseases, rare ophthalmic disorders, gene therapy for ophthalmic indications, or other areas depending on program needs.

Medical Monitoring & Study Oversight

Functions as the Medical Monitor for assigned ophthalmology studies, providing oversight of safety and efficacy data per SOPs and contract scope.

Provides real‑time safety and medical input, including evaluation of adverse events, serious adverse events (SAEs), protocol‑defined ophthalmic safety events (e.g., intraocular inflammation, endophthalmitis, retinal tears/detachments, IOP changes), and deviations.

Collaborates with Safety Monitors to ensure robust safety management throughout the study lifecycle.

Reviews SAE narratives, safety listings, medical coding (MedDRA/WHO Drug), IND/IDE safety reports, CIOMS reports, DSURs, and other aggregate safety deliverables.

Reviews ophthalmology‑specific medical literature, safety alerts, and regulatory safety communications and advises on study‑level actions.

Clinical and Scientific Document Development

Provides medical input into ophthalmology protocols—particularly safety considerations, inclusion/exclusion criteria, ophthalmic assessments, imaging requirements (e.g., OCT, fundus photography, visual acuity testing), and halting rules.

Ensures high‑quality ophthalmology content in clinical trial protocols, investigator brochures, informed consent forms, patient‑reported outcome instruments, ophthalmic imaging manuals, and CRFs.

Contributes to the development of Safety Monitoring Plans, Medical Monitoring Plans, Communication Plans, and training materials.

Supports preparation of safety sections of clinical trial reports, annual reports, and clinical study reports.

Engagement with Experts, Committees, and Regulators

Interfaces with ophthalmology Key Opinion Leaders (KOLs), site investigators, reading centers, imaging vendors, and other specialized partners.

Participates in or presents at safety oversight committees (DSMB/DMC/SMC), answering questions regarding ophthalmic safety signals and study monitoring procedures.

Reviews SOC Charters, minutes, and safety summaries.

Participates in sponsor meetings, investigator meetings, regulatory interactions (FDA/EMA/other), and scientific review meetings.

Business Development & Corporate Contributions

Serves as the ophthalmology medical expert during bid preparation, feasibility strategy, proposal development, and bid defense presentations.

Provides therapeutic‑area perspective to clients, including consultancy on