Ophthalmology Strategy and Medical Monitor

Overview 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 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. Responsibilities 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 ophthalmic indications, endpoint selection, safety considerations, patient populations, and operational risks. Contributes to organizational process improvement, quality assurance, SOP development, internal audits, and professional development activities. Conducts trainings for internal project teams on ophthalmic diseases, assessments, imaging, and trial‑specific medical topics. Performs additional corporate responsibilities such as annual SOP reviews, participation in safety initiatives, and other assigned tasks. May travel between corporate locations, offices of relevant regulatory authorities, and client offices as needed. Required to attend conferences as required. Qualifications Medical Doctor (MD, MBBS, MBBCh, or other equivalent) degree is required. 8 years of working experience, preferably a combination of clinical practice and experience in the area of pharmaceutical medicine (i.e., clinical research, pharmacovigilance, medical affairs, regulatory etc.). Demonstrated clinical medicine expertise through practice experience preferred. Excellent clinical judgement and ability to communicate complex clinical issues in a scientifically sound and understandable way. Experience working with regulatory submissions. Expertise in safety and/or medical monitoring and serious adverse event reporting preferred. Demonstrated experience with or training in clinical trial data collection. Ability to work as a team member and function on a cross‑functional team. Ability to direct activities and encourage positive team‑based culture. Capacity to provide leadership and creativity in the work environment. Excellent interpersonal skills Ability to interact with client counterparts Excellent verbal and written communication skills. Fluent in English. Why work at Emmes? At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including: Flexible Approved Time Off Tuition Reimbursement 401k Retirement Plan Work From Home Anywhere in the US Maternal/Paternal Leave Casual Dress Code & Work Environment CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status. #LI-Remote #J-18808-Ljbffr