JOB TITLE: Clinical Operations Scientist
LOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY or WA.
REPORTS TO: Director, Scientific Operations
SALARY RANGE: $96,000 to $120,000
ABOUT THE POSITION
Aurion Biotech is a clinical-stage biotechnology company dedicated to restoring vision to millions of patients through innovative regenerative therapies. Our lead candidate is an allogeneic cell therapy designed to treat corneal edema secondary to corneal endothelial disease. Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the FDA and has advanced into Phase 3 clinical trials in 2026. Aurion operates as a separate entity with full support from Alcon.
Aurion Biotech is seeking a Clinical Operations Scientist. The Clinical Operations Scientist serves as a scientific resource for assigned studies and programs, contributing to protocol development, data review, interpretation of clinical outcomes, regulatory interactions, and dissemination of scientific findings. In addition, the Clinical Operations Scientist supports the execution of Aurion clinical trials.
KEY RESPONSIBILITIES
- Reports to Clinical Operations and under the guidance of the Sr. Clinical Operations Scientist and Director of Scientific Operations, serves as a scientific partner supporting Clinical Development for one or more ophthalmology clinical programs.
- Supports study startup, conduct, monitoring, closeout, and inspection readiness activities under the guidance of senior team members.
- Participates in investigator meetings, data review meetings, and cross-functional clinical trial team meetings.
- Assists with site feasibility assessments and provides scientific support to investigators and study site personnel.
- Helps identify and escalate scientific and clinical risks related to study execution.
- Contributes to the development of clinical development plans, target product profiles, and overall program strategies.
- Assists in translating development objectives into clinical study designs and operationally feasible protocols.
- Supports the authoring and review of study protocols, informed consent forms, investigator brochures, clinical study reports, and other clinical study documents.
- Provides scientific support for ophthalmic assessments, endpoint selection, imaging strategies, and study conduct activities.
- Participates in the ongoing medical and scientific review of clinical trial data as assigned.
- Collaborates with Biostatistics and Data Management teams to support data quality and integrity.
- Assists in the analysis of emerging safety and efficacy data with guidance from the clinical development team to support program decisions.
- Contributes to the interpretation of clinical study results and the preparation of scientific summaries and presentations for internal stakeholders.
- Supports regulatory submissions, including INDs, CTAs, annual reports, briefing documents, and responses to regulatory authority questions.
- Ensures assigned activities are conducted in compliance with ICH-GCP, applicable regulations, internal SOPs, and ethical standards.
- Contributes to abstracts, manuscripts, posters, and presentations for scientific meetings and peer-reviewed publications.
- Develops collaborative relationships with investigators, study coordinators, key opinion leaders, and scientific advisors.
- Supports the planning and execution of scientific advisory boards and investigator meetings.
- Works closely with Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, Quality Assurance, and external vendors to support study objectives.
- Assists with preparation for regulatory inspections, audits, and quality reviews.
- Maintains current knowledge of ophthalmology, clinical research practices, and applicable regulatory requirements through ongoing learning and professional development.
- Ensure compliance with GCP, ICH, Aurion SOPs, and CRO SOPs
- Performs other duties as assigned by clinical scientific operations to support clinical trials
ABOUT AURION BIOTECH
With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:
- Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
- Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate.
- Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments.
Aurion Biotech has a lot to accomplish in the next few years, and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com.
LIFE AT AURION BIOTECH
We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:
- Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
- Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
- Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.
QUALIFICATIONS AND EDUCATION
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor’s degree with 4-6 years of experience, Master’s degree with 2-4 years of experience or PhD with up to 2 years of experience in clinical research or clinical development. Degree must be in life sciences, nursing, or related field
- Exposure to clinical trial operations, either in a sponsor, CRO, or academic setting supporting Phase 1, 2 or 3 clinical trials, ophthalmology experience 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.
REQUIRED SKILLS AND ABILITIES
- Ability to work effectively in a team environment and across global teams and vendors
- Excellent written, verbal, and interpersonal communication skills; ability to communicate with impact across diverse internal and external stakeholders.
- Demonstrated cultural agility, integrity, and a passion for advancing transformative science.
- Ability to travel up to 15%, candidates local to an office may be asked to periodically travel to the office for meetings or clinical operations department support
- A strong alignment with, and commitment to, Aurion Biotech’s mission, vision, and core values.
