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. 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 evaluation Lead clinical development plans, target product profiles, protocol concepts, study design, eligibility criteria, assessment schedules, statistical analysis considerations, and endpoint strategy Lead endpoint development - including selection, clinical rationale, definition, timing, and alignment with program and regulatory strategy Oversee clinical data analysis in partnership with Biometrics and Clinical Operations, including review plans, interim analyses, data-cleaning priorities, interpretation, and communication of results Provide medical input on reading-center selection and oversight, imaging charters, acquisition standards, and adjudication approaches Draft and review clinical and medical documents: protocols, investigator brochures, informed consent materials, clinical study reports, regulatory briefing materials, and scientific presentations Collaborate with Regulatory Affairs on health-authority submissions, meeting preparation, and clinical rationale for development and registration strategies Support investigator selection, site engagement, investigator meetings, and enrollment strategy Coordinate with independent data monitoring committees to support timely data review Work with Translational Medicine and nonclinical colleagues to integrate natural history, biomarker, imaging, and preclinical evidence into clinical strategy What You Bring M.D. required Experience in biotechnology, pharmaceutical clinical development, academic clinical research, or a closely related setting Experience with OCT and microperimetry analysis and other structural/functional assessments Experience contributing to the design, conduct, medical oversight, analysis, or reporting of interventional clinical studies Strong ability to interpret complex clinical datasets and translate findings into clear conclusions, risks, and recommended actions Working knowledge of GCP and clinical/regulatory documentation requirements Excellent medical and scientific writing, presentation, and verbal communication skills Demonstrated ability to work effectively across Clinical Operations, Biometrics, Regulatory, Medical Affairs, Translational Medicine, and external vendors or investigators Experience in ophthalmology, retina, inherited retinal disease, rare disease, gene therapy, or advanced therapeutics strongly preferred Board 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 #J-18808-Ljbffr