Medical Director, Clinical Development

Opus Genetics | Durham, NC (Hybrid) | Remote Considered - East Coast Preferred Opus Genetics is a clinical-stage gene therapy company focused on inherited retinal diseases. We're building a team of scientists, clinicians, and operators who are deeply committed to advancing treatments for patients with limited options - and doing it with rigor, care, and collaboration. We are looking for a Medical Director to provide senior medical and scientific leadership across our inherited retinal disease clinical development programs. What You'll Do Provide medical oversight and direction across clinical studies, including adverse event review, protocol deviations, eligibility questions, safety surveillance, and benefit-risk evaluationLead clinical development plans, target product profiles, protocol concepts, study design, eligibility criteria, assessment schedules, statistical analysis considerations, and endpoint strategyLead endpoint development - including selection, clinical rationale, definition, timing, and alignment with program and regulatory strategyOversee clinical data analysis in partnership with Biometrics and Clinical Operations, including review plans, interim analyses, data-cleaning priorities, interpretation, and communication of resultsProvide medical input on reading-center selection and oversight, imaging charters, acquisition standards, and adjudication approachesDraft and review clinical and medical documents: protocols, investigator brochures, informed consent materials, clinical study reports, regulatory briefing materials, and scientific presentationsCollaborate with Regulatory Affairs on health-authority submissions, meeting preparation, and clinical rationale for development and registration strategiesSupport investigator selection, site engagement, investigator meetings, and enrollment strategyCoordinate with independent data monitoring committees to support timely data reviewWork with Translational Medicine and nonclinical colleagues to integrate natural history, biomarker, imaging, and preclinical evidence into clinical strategy What You Bring M.D. requiredExperience in biotechnology, pharmaceutical clinical development, academic clinical research, or a closely related settingExperience with OCT and microperimetry analysis and other structural/functional assessmentsExperience contributing to the design, conduct, medical oversight, analysis, or reporting of interventional clinical studiesStrong ability to interpret complex clinical datasets and translate findings into clear conclusions, risks, and recommended actionsWorking knowledge of GCP and clinical/regulatory documentation requirementsExcellent medical and scientific writing, presentation, and verbal communication skillsDemonstrated ability to work effectively across Clinical Operations, Biometrics, Regulatory, Medical Affairs, Translational Medicine, and external vendors or investigatorsExperience in ophthalmology, retina, inherited retinal disease, rare disease, gene therapy, or advanced therapeutics strongly preferredBoard eligibility or certification in ophthalmology or another relevant specialty preferred; active medical license desirable Location: Durham, NC (Hybrid) | Remote considered for East Coast candidates Reports to: Chief Medical Officer $220,000 – $250,000