Medical Director, Clinical Development (biotech research)

Opus Genetics; Durham (NC); Híbrido; USD 180 000 - 240 000; Tempo integral

Resumo da oferta

Opus Genetics seeks a Medical Director to provide senior medical and scientific leadership across inherited retinal disease clinical programs in a Durham, NC hybrid setting with remote consideration for East Coast candidates.

You will oversee clinical development plans, endpoint strategies, and regulatory submissions, coordinating with Biometrics, Regulatory, and Translational Medicine teams to drive safe, effective therapies.

Qualificações

• MD required for leadership in clinical development.
• Experience in biotechnology or pharmaceutical clinical development.
• Expertise with OCT and microperimetry analysis.
• Strong interpretation of complex clinical data and risk assessment.
• Excellent medical writing, presentation, and communication skills.
• Board eligibility or certification in ophthalmology preferred.

Responsabilidades

• Provide medical oversight 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.

Conhecimentos

Clinical development

OCT and microperimetry

Data interpretation

Medical writing

Cross-functional collaboration

GCP knowledge

Formação académica

MD

Descrição da oferta de emprego

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 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