JOB TITLE: Senior Clinical ScientistLOCATION: 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 $188,000Aurion 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
Requirements
QUALIFICATIONS AND EDUCATIONTo 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.
Salary Description
$158,000 to $188,000
