Senior Clinical Operations Scientist

🕒 August 18

🐎 Kentucky, New Hampshire, +10 more states – Remote

🐎 Kentucky – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌶️ New Mexico – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🗿 South Dakota – Remote 🤠 Texas – Remote ☕ Washington – Remote

💵 $158k - $188k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Aurion Biotech

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2022

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 $120M Venture Round - Aurion Biotechnologies on 2022-04

Healthcare • Manufacturing • Biotechnology

Aurion Biotech is a clinical-stage company developing first-in-class regenerative cell therapies to restore vision by treating corneal endothelial disease and other causes of blindness. The company focuses on manufacturing-scale cell therapy platforms, using human donor corneal endothelial cells combined with supportive compounds (e. g. , rho-kinase inhibitor) to repopulate the corneal endothelium, reduce reliance on donor tissue, and enable less-invasive alternatives to graft-based keratoplasty. Aurion conducts global clinical trials, holds FDA Breakthrough Therapy and RMAT designations for its lead product AURN001, and aims to expand access to advanced ophthalmic care worldwide.

📋 Description

• Serve as a clinical scientist and bridging partner to Clinical Development for ophthalmology clinical programs • Support study startup, conduct, monitoring, closeout, and inspection readiness • Participate in investigator meetings, data review meetings, and cross-functional clinical trial team meetings • Support site feasibility assessments and provide scientific guidance to investigators and study sites • Identify and mitigate scientific and clinical risks associated with study execution • Contribute to Clinical Development Plans, Target Product Profiles, and overall development strategies • Translate development objectives into clinical study designs and operationally feasible protocols • Author and review study protocols, informed consent forms, investigator brochures, clinical study reports, and other clinical study documents • Provide scientific expertise for ophthalmic assessments, endpoint selection, imaging strategies, and study conduct • Support ongoing medical and scientific review of clinical trial data • Collaborate with Biostatistics and Data Management to ensure data quality and integrity • Analyze emerging safety and efficacy data to support program decision-making • Interpret clinical study results and prepare scientific summaries and presentations for internal governance committees • Contribute to regulatory submissions, including INDs, CTAs, briefing packages, annual reports, and responses to regulatory authority questions • Ensure studies comply with ICH-GCP, applicable regulations, internal SOPs, and ethical standards • Contribute to abstracts, manuscripts, posters, and presentations for scientific congresses and peer-reviewed journals • Develop and maintain relationships with key opinion leaders, investigators, and scientific advisors • Support and participate in scientific advisory boards and investigator meetings • Collaborate with Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, Quality Assurance, and external vendors • Support preparation for regulatory inspections and audits • Provide scientific mentorship and guidance to junior clinical scientists and study team members • Perform other duties assigned by clinical scientific operations to support clinical trials

🎯 Requirements

• Advanced degree (PharmD, PhD, OD, MS, MPH, or related scientific discipline) in life sciences, nursing, or related field with 7+ years of clinical research or clinical development experience preferred • Candidates with a Bachelor's degree and 10+ years of clinical research or clinical development experience will also be considered • Prior experience supporting late-stage Phase 2/3 clinical programs and leading scientific aspects of clinical studies required • Experience in ophthalmology preferred • Familiarity with study start-up, data cleaning, closeout, and inspection readiness processes • Working knowledge of ICH/GCP guidelines and clinical trial processes • Strong organizational and time management skills; detail-oriented and able to manage multiple tasks • Proficient in Microsoft Office (Word, Excel, PowerPoint) • Experience with data visualization tools, TMF, EDC, and other clinical trial systems • Strong written and verbal interpersonal communication skills • Ability to work effectively in a team environment and across global teams and vendors • Ability to communicate with impact across diverse internal and external stakeholders • Demonstrated cultural agility, integrity, and passion for advancing transformative science • Ability to travel up to 15% • Strong alignment with and commitment to Aurion Biotech’s mission, vision, and core values • Candidates must be based in IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, or WA • Candidates local to an office may be asked to periodically travel to the office for meetings or clinical operations department support

🏖️ Benefits

• Full health insurance for employees and their families • 401(k) matching • Employee Assistance Program (EAP) • Flexible Spending Account (FSA) • Generous PTO • Competitive compensation packages • Paid parking • Subsidized commuter passes • In-office catered lunches • Team events • Community projects • Remote work arrangement • Opportunity for scientific mentorship and guidance