Medical Director, Clinical Development (biotech research)

Job Description

Medical Director, Clinical Development

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Opus Genetics | Durham, NC (Hybrid) | Remote Considered - East Coast Preferred

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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.

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We are looking for a Medical Director to provide senior medical and scientific leadership across our inherited retinal disease clinical development programs.

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What You'll Do:

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• Provide medical oversight and direction across clinical studies, including adverse event review, protocol deviations, eligibility questions, safety surveillance, and benefit-risk evaluation
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• Lead clinical development plans, target product profiles, protocol concepts, study design, eligibility criteria, assessment schedules, statistical analysis considerations, and endpoint strategy
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• Lead endpoint development - including selection, clinical rationale, definition, timing, and alignment with program and regulatory strategy
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• Oversee clinical data analysis in partnership with Biometrics and Clinical Operations, including review plans, interim analyses, data-cleaning priorities, interpretation, and communication of results
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• Provide medical input on reading-center selection and oversight, imaging charters, acquisition standards, and adjudication approaches
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• Draft and review clinical and medical documents: protocols, investigator brochures, informed consent materials, clinical study reports, regulatory briefing materials, and scientific presentations
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• Collaborate with Regulatory Affairs on health-authority submissions, meeting preparation, and clinical rationale for development and registration strategies
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• Support investigator selection, site engagement, investigator meetings, and enrollment strategy
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• Coordinate with independent data monitoring committees to support timely data review
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• Work with Translational Medicine and nonclinical colleagues to integrate natural history, biomarker, imaging, and preclinical evidence into clinical strategy
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What You Bring:

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• M.D. required
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• Experience in biotechnology, pharmaceutical clinical development, academic clinical research, or a closely related setting
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• Experience with OCT and microperimetry analysis and other structural/functional assessments
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• Experience contributing to the design, conduct, medical oversight, analysis, or reporting of interventional clinical studies
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• Strong ability to interpret complex clinical datasets and translate findings into clear conclusions, risks, and recommended actions
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• Working knowledge of GCP and clinical/regulatory documentation requirements
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• Excellent medical and scientific writing, presentation, and verbal communication skills
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• Demonstrated ability to work effectively across Clinical Operations, Biometrics, Regulatory, Medical Affairs, Translational Medicine, and external vendors or investigators
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• Experience in ophthalmology, retina, inherited retinal disease, rare disease, gene therapy, or advanced therapeutics strongly preferred
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• Board eligibility or certification in ophthalmology or another relevant specialty preferred; active medical license desirable
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Location: Durham, NC (Hybrid) | Remote considered for East Coast candidates

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Reports to: Chief Medical Officer

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$220,000 – $250,000