Senior Clinical Scientist

🔥 1 minute ago

🐎 Kentucky, New Hampshire, +11 more states – Remote

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

💵 $158k - $188k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 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 scientific lead for one or more ophthalmology clinical programs • Contribute to clinical strategy and clinical development plans • Translate scientific and medical objectives into operationally feasible clinical trial designs • Identify clinical risks and develop mitigation strategies • Lead or support development of study protocols, amendments, informed consent documents, case report forms, and other study documents • Support site feasibility and investigator selection • Provide scientific oversight throughout study startup, enrollment, conduct, database lock, and closeout • Address protocol questions, eligibility determinations, deviations, and study conduct challenges with Clinical Operations • Support Medical Monitoring and patient cleaning activities • Participate in investigator, study team, safety/data review, vendor, and scientific advisory board meetings • Ensure studies comply with protocols, ICH-GCP, regulations, and Aurion SOPs • Partner with Biometrics and Data Management on data review plans and data quality • Review clinical, efficacy, safety, imaging, biomarker, and pharmacokinetic data • Interpret emerging study results and provide clinical insights • Contribute to regulatory meeting preparation and interactions with global health authorities • Support briefing documents, agency responses, and submission documents • Contribute scientific content for INDs, CTAs, annual reports, clinical study reports, and marketing applications • Lead or support clinical study reports, abstracts, posters, manuscripts, and scientific presentations • Support publication strategy and dissemination of clinical data • Present study findings to senior leadership, investigators, advisory boards, and scientific audiences • Partner with internal functions and external CRO, vendor, and imaging-center partners • Develop relationships with investigators, key opinion leaders, and scientific advisors • Support inspection readiness and participate in audits and regulatory inspections • Contribute to process improvement, Clinical Science processes, standards, and best practices • Provide scientific mentorship to Clinical Scientists and cross-functional team members • Support a collaborative, high-performance culture aligned with Aurion’s mission and values

🎯 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 is 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 interpersonal and communication skills, both written and verbal • Ability to work effectively in a team environment and across global teams and vendors • Excellent written, verbal, and interpersonal communication skills • Demonstrated cultural agility, integrity, and a 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

🏖️ Benefits

• Full health insurance for employees and their families • 401(k) matching • Employee Assistance Program (EAP) • Flexible Spending Account (FSA) • Generous PTO • Paid parking • Subsidized commuter passes • In-office catered lunches • Team events • Community projects • Competitive compensation packages • Remote work arrangement • Periodic office travel/meetings for candidates local to an office