Senior Clinical Scientist

This is a fully remote position, open to applicants in Kentucky, +12 more states.

📋 Description

• Act as the scientific leader for one or more clinical programs in ophthalmology.

• Contribute to the development of clinical strategies and plans.

• Convert scientific and medical goals into practical clinical trial designs.

• Recognize clinical risks and formulate mitigation strategies.

• Lead or assist in the creation of study protocols, amendments, informed consent documents, case report forms, and other essential study documents.

• Aid in site feasibility assessments and the selection of investigators.

• Offer scientific guidance throughout the phases of study startup, enrollment, execution, database lock, and closeout.

• Address protocol inquiries, eligibility assessments, deviations, and challenges related to study conduct with the Clinical Operations team.

• Assist with Medical Monitoring and patient data cleaning tasks.

• Engage in meetings with investigators, study teams, safety/data review committees, vendors, and scientific advisory boards.

• Ensure compliance of studies with protocols, ICH-GCP, regulations, and Aurion SOPs.

• Collaborate with Biometrics and Data Management on data review strategies and data integrity.

• Evaluate clinical, efficacy, safety, imaging, biomarker, and pharmacokinetic information.

• Analyze emerging study findings and offer clinical insights.

• Participate in the preparation for regulatory meetings and interactions with global health authorities.

• Assist in the creation of briefing documents, responses to agencies, and submission materials.

• Provide scientific contributions for INDs, CTAs, annual reports, clinical study reports, and marketing applications.

• Lead or assist in the development of clinical study reports, abstracts, posters, manuscripts, and scientific presentations.

• Support the publication strategy and dissemination of clinical findings.

• Present study results to senior leadership, investigators, advisory boards, and scientific audiences.

• Collaborate with internal departments and external CROs, vendors, and imaging centers.

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

• Prepare for inspections and take part in audits and regulatory assessments.

• Contribute to process enhancements, Clinical Science methodologies, standards, and best practices.

• Mentor Clinical Scientists and cross-functional team members scientifically.

• Foster a collaborative, high-performance culture aligned with Aurion’s mission and values.

⛳️ Requirements

• An advanced degree (PharmD, PhD, OD, MS, MPH, or a related scientific field) in life sciences, nursing, or a similar area with over 7 years of experience in clinical research or clinical development (preferred).

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

• Prior experience in supporting late-stage (Phase 2/3) clinical programs and leading the scientific aspects of clinical studies is essential.

• Experience in ophthalmology is preferred.

• Knowledge of study startup, data cleaning, closeout, and inspection readiness processes.

• Familiarity with ICH/GCP guidelines and clinical trial processes.

• Exceptional organizational and time management abilities; detail-oriented and capable of handling multiple tasks.

• Proficient in Microsoft Office Suite (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 operate efficiently in a team setting and collaborate across global teams and vendors.

• Excellent written and verbal communication abilities.

• Proven cultural agility, integrity, and a dedication to advancing transformative science.

• Willingness to travel up to 15%.

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

🏝️ Benefits

• Comprehensive health insurance for employees and their families.

• 401(k) matching program.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Generous paid time off (PTO).

• Covered parking expenses.

• Subsidized commuter passes.

• In-office catered lunches.

• Team-building events.

• Opportunities for community engagement projects.

• Competitive compensation packages.

• Options for remote work arrangements.

• Occasional office travel/meetings for candidates located near an office.