Director, Clinical Science in Berkeley, California at RAY THERAPEUTICS INC
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Job Description
Director of Clinical Science, Berkeley, CA, Hybrid
The Director of Clinical Science is a key clinical development leader responsible for providing scientific and medical input across Ray Therapeutics’ clinical-stage programs. This individual will help translate development strategy into rigorous clinical plans, protocols, analyses, and regulatory deliverables, with a focus on advancing innovative optogenetic therapies for retinal degenerative diseases.
The Director will partner closely with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Medical Affairs, Safety, Translational Sciences, CMC, and external investigators to ensure that clinical studies are scientifically sound, operationally feasible, patient focused, and executed to high standards of quality and compliance. The role will contribute to clinical development plans, interpretation and communication of emerging data, and preparation of materials for health authorities, investigators, scientific meetings, and internal governance.
Formula for Success: Combining strong clinical-science expertise, strategic thinking, and hands-on execution to advance clinical programs from early development through pivotal studies; you will:
- Contribute to clinical development strategy, including target product profiles, clinical development plans, study concepts, and evidence-generation plans
- Lead or support the development of scientifically rigorous clinical protocols, amendments, informed consent documents, investigator brochures, clinical study reports, and related documents
- Define clinically meaningful endpoints, eligibility criteria, assessment schedules, and analysis approaches in collaboration with Biostatistics and cross-functional partners
- Provide clinical-science leadership to cross-functional study teams and ensure alignment between scientific objectives and operational execution
- Review, interpret, and communicate clinical safety, efficacy, and biomarker data; identify emerging trends, risks, and opportunities
- Support data-review activities, including development of review plans, listings, data visualizations, and preparation for database lock
- Partner with external investigators, key opinion leaders, clinical vendors, and scientific advisors to inform program strategy and study conduct
- Contribute to regulatory strategy and author clinical sections of briefing documents, responses to health-authority questions, and submissions in the United States and other regions
- Prepare and present clinical program updates to internal governance bodies, senior leadership, investigators, and external stakeholders
- Lead or support abstracts, posters, presentations, and manuscripts that communicate clinical findings accurately and responsibly
- Maintain current knowledge of retinal disease, optogenetics, gene therapy, clinical-development methodology, and the competitive landscape
- Ensure clinical-science activities comply with applicable regulations, ICH-GCP, company procedures, and high standards of scientific integrity
Your Qualifications include:
- Advanced degree in a life-science or health-science discipline required; MD, OD, PhD, PharmD, or equivalent degree strongly preferred
- At least 8 years of relevant experience in clinical development, clinical research, or a related function within biotechnology, pharmaceutical, or academic settings
- Experience supporting clinical programs across multiple stages of development, including early-phase and later-stage studies
- Ophthalmology experience, particularly in retinal disease, is strongly preferred; experience in gene therapy, AAV therapeutics, optogenetics, or advanced therapeutics is highly desirable
- Demonstrated ability to author high-quality clinical protocols, clinical study reports, regulatory documents, scientific presentations, or manuscripts
- Strong understanding of clinical-trial design, endpoint selection, data interpretation, and benefit-risk assessment
- Working knowledge of FDA and global regulatory expectations, ICH-GCP, and applicable clinical-development standards
- Ability to synthesize complex clinical and scientific information, identify implications, and communicate clear recommendations
- Excellent written, verbal, and presentation skills, with close attention to scientific accuracy and detail
- Collaborative, proactive, and adaptable working style, with the ability to influence cross-functional teams without direct authority
- Ability to manage multiple priorities in a fast-paced, growing biotechnology company
- Ability to travel approximately 20%
- Ability to work in our Berkeley office 3 days per week
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