Director, Clinical Science

Ray Therapeutics, Inc.; Berkeley (CA); Híbrido; USD 250 000 - 285 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual performance-based bonus

Comprehensive benefits package

Berkeley office 3 days/week

Resumo da oferta

Ray Therapeutics, Inc. seeks a Director of Clinical Science to translate development strategy into rigorous clinical plans, protocols, analyses, and regulatory deliverables for optogenetic retinal therapies.

Lead cross-functional teams, define endpoints, and ensure high standards of scientific integrity. The role requires advanced life-science credentials, 8+ years in clinical development, ophthalmology experience, and strong collaboration across Regulatory, Biostatistics, Medical Affairs, and

Qualificações

• Advanced degree required; MD/PhD strongly preferred.
• 8+ years in clinical development in biotech/pharma/academic settings.
• Experience in ophthalmology retinal disease and gene therapy is highly desirable.
• Ability to author high-quality protocols, study reports, and regulatory documents.
• Strong knowledge of FDA/ICH-GCP and clinical development standards.
• Excellent written and verbal communication; cross-functional influence.

Responsabilidades

• Contribute to clinical development strategy, plans, and evidence-generation concepts.
• Lead development of clinically rigorous protocols, amendments, ICFs, investigator brochures, and study reports.
• Define clinically meaningful endpoints, eligibility, scheduling, and analysis approaches with Biostatistics.
• Provide clinical-science leadership to cross-functional study teams and align objectives with execution.
• Review and interpret safety, efficacy, and biomarker data; identify trends, risks, and opportunities.
• Support data-review activities and prepare regulatory submissions and briefing documents.

Conhecimentos

Clinical leadership

Cross-functional collaboration

Regulatory documentation

Study design endpoints

ICH-GCP knowledge

Communication skills

Travel readiness

Retina/ophthalmology experience

Formação académica

Advanced degree in life-science/health-science

MD/OD/PhD/PharmD or equivalent preferred

Descrição da oferta de emprego

Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.

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

Compensation Range and Benefits: For this role, the anticipated base salary range will be $250,000 - $285,000, determined based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to, skills, education, and experience. Ray Therapeutics also offers an annual performance-based bonus and a comprehensive benefits package.

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.