Senior Scientist, Preclinical Ophthalmology

Job Overview

Pharmaron is seeking a highly motivated Study Director/Senior Scientist/Scientist to join our Preclinical Ophthalmology team. The successful candidate will serve as a Study Director for GLP and non-GLP ophthalmology studies and provide scientific leadership and project management for ocular drug, biologic, gene therapy, cell therapy, and medical device development programs. This role is responsible for designing, executing, interpreting, and reporting preclinical ophthalmology studies while ensuring the delivery of high-quality, scientifically rigorous, and regulatory-compliant services to clients.

Key Responsibilities

Scientific Leadership

• Serve as the scientific lead for preclinical ophthalmology studies and programs.
• Act as Study Director for GLP and non-GLP ophthalmology studies.
• Design, coordinate, monitor, and oversee in vivo ophthalmology studies in rodent and large animal models.
• Provide scientific leadership in study design, endpoint selection, model development, and data interpretation.
• Support business development activities, scientific proposals, study costing, client meetings, and technical presentations.
• Serve as the primary scientific contact for clients throughout study execution.

Ophthalmic Procedures and Disease Models

• Oversee and perform ocular dosing procedures including: Intravitreal injection, Subretinal injection, Suprachoroidal injection, Intracameral injection, Subconjunctival injection, Topical ocular administration, Systemic administration when applicable.
• Design and execute studies in anterior and posterior segment disease models, including: Retinal degeneration, Age-related macular degeneration (AMD), Geographic atrophy (GA), Diabetic retinopathy, Choroidal neovascularization (CNV), Glaucoma and ocular hypertension, Corneal disease and wound healing, Dry eye disease, Ocular inflammation and infectious disease models.

Imaging, Functional Assessments, and Data Interpretation

• Perform, oversee, and interpret ophthalmic imaging and functional assessments including: Optical Coherence Tomography (OCT), Fluorescein Angiography (FA), Indocyanine Green Angiography (ICGA), Fundus Photography, Slit Lamp Biomicroscopy, Specular Microscopy, Anterior Segment Imaging (Anterion or equivalent systems), Electroretinography (ERG), Pattern ERG (PERG), Optokinetic Response (OKR), Intraocular Pressure (IOP) Assessments.
• Correlate imaging and functional data with histopathology findings.
• Review and interpret ophthalmic endpoints and prepare scientific conclusions and recommendations.

Study Management and Compliance

• Prepare, review, and approve study protocols, amendments, deviations, change controls, SOPs, and study reports.
• Author final study reports and contributing scientist reports.
• Monitor study conduct to ensure quality, compliance, and data integrity.
• Ensure documentation complies with GLP requirements and ALCOA principles.
• Work closely with Quality Assurance (QA) to maintain regulatory compliance.
• Serve as Subject Matter Expert (SME) during client audits, regulatory inspections, and QA audits.
• Lead root cause investigations, CAPA activities, and continuous process improvement initiatives.

Cross-Functional Collaboration

• Collaborate with pathology, formulation, bioanalysis, toxicology, molecular biology, and analytical teams to ensure successful study execution.
• Support IND-enabling studies and translational research programs.
• Contribute scientific expertise to protocol development, publication preparation, and client consultation activities.

Team Leadership

• Mentor, train, and supervise scientists, research associates, and technical staff.
• Provide technical training on ophthalmic procedures, imaging platforms, disease models, and data interpretation.
• Promote a culture of scientific excellence, innovation, quality, and client service.

What We're Looking For

Education

• Scientist: MS in Ophthalmology, Vision Science, Pharmacology, Biology, Biomedical Sciences, or related field with a minimum of 5 years of relevant ophthalmology experience.
• Senior Scientist / Study Director: PhD in Ophthalmology, Vision Science, Pharmacology, Biology, Biomedical Sciences, or related field with a minimum of 2 years of relevant industry experience.
• Additional industry experience preferred for senior-level candidates.

Technical Experience

• Hands-on experience conducting preclinical ophthalmology studies.
• Experience with ophthalmic imaging including OCT, FA, ICGA, fundus imaging, slit lamp examination, anterior segment imaging, and specular microscopy.
• Experience with ERG, PERG, OKR, and ocular imaging data interpretation.
• Experience with rodent and large animal ophthalmology models (rabbit, pig, dog, and/or non-human primate preferred).
• Experience with ocular drug delivery techniques including intravitreal, subretinal, suprachoroidal, and intracameral administration.
• Strong understanding of ocular anatomy, retinal biology, and translational ophthalmology.

Regulatory Experience

• Experience serving as a Study Director, Principal Investigator, or lead scientist in GLP and/or regulated studies.
• Working knowledge of FDA, OECD, and GLP regulations.
• Experience supporting audits, inspections, quality systems, and regulatory documentation.

Preferred Qualifications

• Experience supporting ophthalmic drug, biologic, gene therapy, cell therapy, and medical device development programs.
• Experience with IND-enabling efficacy, safety, and toxicology studies.
• Histopathology interpretation experience.
• Experience with image analysis software and quantitative imaging endpoints.
• Prior CRO experience.
• Strong project management skills with the ability to manage multiple studies, timelines, budgets, and client deliverables.
• Proven ability to interact effectively with clients and contribute to business growth.
• Strong scientific writing, presentation, and communication skills.