Senior Clinical Scientist

Aurion Biotech; Northern (KY); Hybrid; USD 158,000 - 188,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid parking

Team events

Job summary

Aurion Biotech, a clinical-stage ophthalmology company, seeks a Senior Clinical Scientist to lead scientific strategy across trials from protocol to regulatory submission. You will work with Clinical Operations, Medical Affairs, Biostatistics, and external CROs to advance corneal therapies.

Ideal candidates bring 7+ years in clinical development, PhD/MD-equivalent degrees, and strong ICH-GCP knowledge, with travel up to 15% and a passion for transformative vision-restoration science.

Qualifications

• Advanced degree (PharmD, PhD, OD, MS, MPH, or related) with 7+ years of clinical research/clinical development experience.
• Bachelor's degree with 10+ years of clinical research or clinical development experience will be considered.
• Experience leading late-stage (Phase 2/3) ophthalmology programs is preferred.
• Familiarity with ICH-GCP guidelines and clinical trial processes.
• Proficient in Microsoft Office; experience with data visualization tools, TMF, and EDC systems.
• Strong interpersonal and communication skills across diverse stakeholders.

Responsibilities

• Contribute to clinical strategy and development plans.
• Translate objectives into feasible trial designs.
• Identify clinical risks and mitigation strategies.
• Lead protocol development, amendments, and essential clinical documents.
• Support site feasibility and investigator selection.
• Provide scientific oversight through startup, enrollment, data lock, and closeout.
• Collaborate with operations, medical affairs, biostatistics, and external partners.
• Prepare briefing documents and regulatory submissions.

Skills

Team collaboration

Communication skills

Cultural agility

Travel willingness

Mission alignment

Microsoft Office

Education

Advanced degree in life sciences

Bachelor's degree +10 years experience

Tools

Microsoft Office

Job description

JOB TITLE: Senior Clinical 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, Clinical Science

SALARY RANGE: $158,000 to $188,000

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 highly motivated and experienced Senior Clinical Scientist to join the Clinical Development organization. Reporting to the Director of Clinical Science, this individual will serve as the scientific lead for one or more ophthalmology clinical programs and will play a critical role in the design, execution, analysis, and interpretation of clinical trials.

The Senior Clinical Scientist will collaborate closely with Clinical Operations, Medical Affairs, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Quality, and external partners to ensure the successful advancement of Aurion's clinical development programs. This individual will provide scientific leadership throughout the clinical trial lifecycle, from protocol development through clinical study reporting and regulatory submissions.

KEY RESPONSIBILITIES

• Contribute to the development of clinical strategy and clinical development plans
• Translate scientific and medical objectives into operationally feasible clinical trial designs
• Identify clinical risks and proactively develop mitigation strategies
• Lead and/or support the development of study protocols, protocol amendments, informed consent documents, case report forms, and other clinical study documents
• Support site feasibility and investigator selection activities, as assigned
• Provide ongoing scientific oversight and support throughout study startup, enrollment, conduct, database lock, and study closeout
• Collaborate with Clinical Operations to address protocol questions, eligibility determinations, deviations, and study conduct challenges
• Support Medical Monitoring activities and contribute to patient cleaning activities
• Participate in investigator meetings, study team meetings, safety/data review meetings, and vendor meetings
• Support scientific advisory boards and investigator meetings
• Ensure clinical studies are conducted in accordance with protocol requirements, ICH-GCP, applicable regulations, and Aurion SOPs
• Lead and/or partner with Biometrics and/or Data Management to develop data review plans and ensure data quality
• Lead and/or support ongoing review of clinical, efficacy, safety, imaging, and biomarker/pharmacokinetic data
• Review and interpret emerging study results and provide meaningful clinical insights for assigned programs
• Contribute to regulatory meeting preparation and interactions with global health authorities, as assigned
• Support preparation of briefing documents, responses to agency questions, and submission documents, as assigned
• Contribute scientific content for INDs, CTAs, annual reports, clinical study reports, and marketing applications
• Lead and/or support the development of clinical study reports, abstracts, posters, manuscripts, and scientific presentations
• Support publication strategy and dissemination of clinical data
• Present study findings internally and externally to senior leadership, investigators, advisory boards, and scientific audiences
• Partner closely with Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Pharmacovigilance, Quality Assurance, and external 3rd party vendors including CRO partners and imaging centers
• Develop strong collaborative relationships with investigators, key opinion leaders, and scientific advisors
• Support inspection readiness activities and participate in audits and regulatory inspections
• Contribute to continuous process improvement initiatives within Clinical Development
• Contribute to the development of Clinical Science processes, standards, and best practices
• Provide guidance and scientific mentorship to Clinical Scientists and cross-functional team members
• Support a collaborative, high-performance culture aligned with Aurion's mission and values

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.

• 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.

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 department support
• A strong alignment with, and commitment to, Aurion Biotech’s mission, vision, and core values.