Senior Clinical Operations Scientist

This is a fully remote position, open to applicants in Kentucky, +11 more states.

📋 Description

• Act as a clinical scientist and a key liaison to Clinical Development for ophthalmology clinical programs.

• Assist with study initiation, execution, monitoring, closure, and preparation for inspections.

• Engage in investigator meetings, data review sessions, and cross-functional clinical trial team discussions.

• Aid in site feasibility evaluations and provide scientific advice to investigators and study sites.

• Recognize and address scientific and clinical risks linked to study implementation.

• Contribute to Clinical Development Plans, Target Product Profiles, and overall development strategies.

• Convert development goals into clinical study designs and operationally viable protocols.

• Draft and review study protocols, informed consent documents, investigator brochures, clinical study reports, and other clinical study materials.

• Offer scientific expertise for ophthalmic evaluations, endpoint selection, imaging strategies, and study execution.

• Support the ongoing medical and scientific analysis of clinical trial data.

• Work alongside Biostatistics and Data Management to maintain data quality and integrity.

• Assess emerging safety and efficacy data to support program decision-making processes.

• Interpret clinical study outcomes and create scientific summaries and presentations for internal governance committees.

• Contribute to regulatory submissions, including INDs, CTAs, briefing documents, annual reports, and responses to queries from regulatory authorities.

• Ensure studies adhere to ICH-GCP, relevant regulations, internal SOPs, and ethical standards.

• Assist in the preparation of abstracts, manuscripts, posters, and presentations for scientific conferences and peer-reviewed journals.

• Build and nurture relationships with key opinion leaders, investigators, and scientific advisors.

• Support and engage in scientific advisory boards and investigator meetings.

• Collaborate with Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, Quality Assurance, and external partners.

• Aid in the preparation for regulatory inspections and audits.

• Provide scientific mentorship and guidance to junior clinical scientists and study team members.

• Execute other tasks assigned by clinical scientific operations to support clinical trials.

⛳️ Requirements

• An advanced degree (PharmD, PhD, OD, MS, MPH, or a related scientific field) in life sciences, nursing, or a comparable area with a preference for candidates with 7+ years of clinical research or clinical development experience.

• Candidates holding a Bachelor's degree with 10+ years of clinical research or clinical development experience will also be considered.

• Previous experience in supporting late-stage Phase 2/3 clinical programs and leading scientific components of clinical studies is essential.

• Experience in ophthalmology is advantageous.

• Knowledge of study initiation, data cleaning, closure, and inspection readiness processes is required.

• Familiarity with ICH/GCP guidelines and clinical trial methodologies is necessary.

• Strong organizational and time management capabilities; detail-oriented and adept at managing multiple tasks.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).

• Experience with data visualization tools, TMF, EDC, and other clinical trial systems is beneficial.

• Excellent written and verbal communication skills.

• Ability to collaborate effectively in a team setting and across global teams and vendors.

• Capacity to communicate impactful messages to a diverse range of internal and external stakeholders.

• Proven cultural adaptability, integrity, and enthusiasm for advancing transformative science.

• Willingness to travel up to 15% of the time.

• Strong alignment with and dedication to Aurion Biotech’s mission, vision, and core values.

• Candidates must reside in IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, or WA.

• Candidates local to an office may be required to travel to the office periodically for meetings or support for the clinical operations department.

🏝️ Benefits

• Comprehensive health insurance for employees and their families.

• 401(k) matching contributions.

• Employee Assistance Program (EAP) available.

• Flexible Spending Account (FSA) options offered.

• Generous paid time off (PTO) policy.

• Competitive salary packages.

• Paid parking facilities.

• Subsidized commuter passes available.

• In-office catered lunch provisions.

• Team-building events.

• Community involvement projects.

• Remote work flexibility.

• Opportunities for scientific mentorship and guidance.