Principal Clinical Research Scientist

• Represent Clinical Science as a core team member on critical projects
• Liaise between project and functional teams and coordinate with Clinical Operations and Project Management partners
• Deliver clinical programs on time, within budget, and in compliance with regulations and SOPs
• Build collaborative relationships across business platforms and with cross-functional partners including Global Strategic Marketing, Medical Affairs, Regulatory Affairs, and R&D
• Lead interpretation and dissemination of evidence through Clinical Study Reports, abstracts, manuscripts, and MDR-related documents such as CERs, PMCFs, and Clinical Plans
• Contribute to clinical scientific discussions with regulatory agencies supporting clinical and regulatory strategy
• Support proposed investigations, evidence review for marketing authorization, and regulatory inspections
• Engage and collaborate with key opinion leaders and regulatory agencies
• Build relationships through professional and technical societies
• Perform other related duties as assigned by management

• Advanced degree in a scientific discipline required
• OD, MD/Ophthalmologist, or PhD in Vision Science/related field strongly preferred
• 5+ years of ophthalmic clinical research experience
• Deep understanding of eye care, ophthalmic devices, vision science, or related therapeutic areas
• Experience supporting product development and lifecycle management
• Led clinical studies or clinical programs, not just participated in them
• Experience designing studies and selecting endpoints
• Demonstrated leadership on complex, cross-functional projects
• Personally authored or substantially contributed to clinical study protocols, Clinical Study Reports, scientific abstracts, and manuscripts/publications
• Ability to interpret study results independently
• Comfortable working with biostatisticians on sample size assumptions, endpoint strategy, statistical analysis plans, and interpretation of results
• Demonstrated ability to influence without direct authority
• Experience partnering with R&D, Regulatory Affairs, Marketing, Medical Affairs, and Clinical Operations
• Strong technical writing ability required
• Understanding of biostatistics as applied to study data required
• Proficient with computers and software programs required
• Up to 10% domestic or international travel required

Demonstrates expertise in ophthalmic clinical research, including study design, regulatory compliance, and technical writing. Proven ability to lead cross-functional teams and engage with regulatory agencies while delivering clinical programs effectively.

• Ophthalmic Clinical Research Experience
• Clinical Study Design
• Technical Writing
• Regulatory Compliance
• Leadership on Cross-Functional Projects

• Clinical Study Protocols
• Statistical Analysis Plans
• Endpoint Strategy
• Clinical Study Reports
• Evidence Review
• Clinical Plans
• MDR-Related Documents
• Biostatistics
• Ophthalmic Devices
• Vision Science

• Influencing Without Authority
• Collaboration
• Relationship Building

• Advanced Degree in Scientific Discipline
• OD, MD/Ophthalmologist, or PhD in Vision Science

• Clinical Operations
• Project Management
• Global Strategic Marketing
• Medical Affairs
• Regulatory Affairs
• R&D
• Clinical Programs
• Marketing Authorization
• Regulatory Inspections
• Professional Societies

• Computers
• Software Programs