Senior Clinical Scientist

Accountabilities:

As a Senior Clinical Scientist, you will provide scientific leadership across assigned ophthalmology clinical programs and help ensure studies are designed, executed, analyzed, and communicated effectively. You will work across the clinical development organization and with external partners to translate scientific objectives into high-quality clinical programs.

• Contribute to clinical strategy and the development of clinical development plans.
• Translate scientific and medical objectives into operationally feasible clinical trial designs.
• Identify clinical development risks and proactively develop appropriate mitigation strategies.
• Lead or support the development of study protocols, amendments, informed consent documents, case report forms, and other clinical study materials.
• Support site feasibility assessments and investigator selection activities.
• Provide scientific oversight throughout study startup, enrollment, study conduct, database lock, and closeout.
• Partner with Clinical Operations to address protocol questions, eligibility determinations, deviations, and study conduct challenges.
• Support medical monitoring activities and contribute to patient and clinical data cleaning.
• Participate in investigator meetings, study team meetings, safety and data review meetings, advisory boards, and vendor meetings.
• Ensure clinical studies are conducted in accordance with protocols, ICH-GCP, applicable regulations, and organizational procedures.
• Partner with Biometrics and Data Management teams to develop data review plans and maintain high standards of data quality.
• Review and interpret clinical, efficacy, safety, imaging, biomarker, and pharmacokinetic data as applicable.
• Evaluate emerging study results and provide meaningful scientific and clinical insights to support program decisions.
• Contribute to regulatory meeting preparation and interactions with global health authorities.
• Support the preparation of regulatory briefing materials, responses to agency questions, and submission documents.
• Contribute scientific content to INDs, CTAs, annual reports, clinical study reports, and marketing applications.
• Lead or support the development of clinical study reports, abstracts, posters, manuscripts, and scientific presentations.
• Support publication strategy and the dissemination of clinical data to scientific audiences.
• Present study findings to senior leadership, investigators, advisory boards, and external scientific stakeholders.
• Develop strong working relationships with investigators, key opinion leaders, scientific advisors, CROs, imaging centers, and other external partners.
• Support inspection readiness, audits, and regulatory inspections.
• Contribute to continuous improvement of Clinical Development processes, standards, and best practices.
• Provide scientific guidance and mentorship to Clinical Scientists and cross-functional colleagues.
• Promote a collaborative, high-performance environment focused on advancing clinical programs and transformative science.

Requirements

The role requires substantial clinical research or clinical development experience, preferably within late-stage programs and ophthalmology. You should combine strong scientific judgment with excellent communication, organizational, and cross-functional collaboration skills, and be comfortable working across global teams and external partners.

• Advanced degree such as PharmD, PhD, OD, MS, MPH, or a related scientific, life sciences, or nursing discipline, with 7+ years of clinical research or clinical development experience preferred.
• Candidates with a bachelor's degree and 10+ years of relevant clinical research or clinical development experience will also be considered.
• Required experience supporting late-stage Phase 2/3 clinical programs and leading the scientific aspects of clinical studies.
• Experience in ophthalmology is preferred.
• Familiarity with clinical study startup, data cleaning, database lock, closeout, and inspection readiness processes.
• Strong working knowledge of ICH-GCP guidelines and clinical trial processes.
• Experience contributing to clinical strategy, protocols, clinical study reports, regulatory submissions, and scientific communications.
• Strong ability to analyze and interpret clinical data and translate findings into meaningful scientific insights.
• Excellent organizational and time-management skills, with the ability to manage multiple priorities and deliver high-quality work.
• Strong attention to detail and commitment to data quality and clinical study integrity.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Familiarity with data visualization tools, Trial Master File (TMF) systems, Electronic Data Capture (EDC) platforms, and other clinical trial technologies.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to communicate complex scientific information clearly and effectively to diverse technical and non-technical stakeholders.
• Strong collaboration skills and the ability to work effectively across global teams, functions, vendors, and external partners.
• Demonstrated cultural agility, integrity, adaptability, and scientific curiosity.
• Ability to provide mentorship and scientific guidance to colleagues.
• Willingness to travel up to 15%; employees located near an office may also be asked to travel periodically for meetings or departmental support.
• Must be authorized to work in the United States without employer sponsorship.
• Candidates must be based in one of the eligible states: WA, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, or IN.

Benefits

• Annual salary range of $158,000–$188,000.
• Fully remote position within the United States for candidates in eligible states.
• Comprehensive health insurance coverage for employees and their families.
• 401(k) matching.
• Employee Assistance Program (EAP).
• Flexible Spending Account (FSA).
• Generous paid time off (PTO).
• Competitive total rewards package.
• Paid parking and subsidized commuter passes where applicable.
• Catered lunches for employees working from an office.
• Team events and community-oriented activities.
• Opportunity to contribute to innovative regenerative therapies and transformative clinical science.
• Exposure to late-stage clinical development, regulatory interactions, scientific publications, and global clinical programs.
• Opportunities to collaborate with multidisciplinary clinical, scientific, regulatory, and operational teams.
• Professional growth through scientific leadership, mentorship, and participation in complex clinical development initiatives.