Ophthalmology Medical Monitor & Strategy Lead

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Founded over 47 years ago, Emmes has become one of the primary clinical research providers to the U.S. government before expanding into public‑private partnerships and commercial biopharma. The company 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. If you share our motivations and passion for research, come join us as we embed innovation into the fabric of our company. 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. It is primarily responsible 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. Travel is required between corporate locations, offices of relevant regulatory authorities, and client offices, and attendance at conferences may be necessary. Qualifications Medical Doctor (MD, MBBS, MBBCh, or equivalent) degree is required. 8 years of working experience, preferably a combination of clinical practice and experience in pharmaceutical medicine (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. Benefits Flexible Approved Time Off Tuition Reimbursement 401(k) Retirement Plan Work From Home Anywhere in the U.S. Maternal/Paternal Leave Casual Dress Code & Work Environment Community engagement program through Emmes Cares 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. #J-18808-Ljbffr Emmes Group