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Senior Clinical Trial Assistant (Sr. CTA) - Clinical Development Operations Location: San Francisco / South San Francisco, CA (Hybrid - 3 days onsite/week; remote considered) Our client is a clinical-stage biotech developing small molecule medicines using structure-based and computational drug discovery. They’re building out their Clinical Development Operations function and need a strong Sr. CTA to support late-phase clinical study execution in a smaller-company environment. What you’ll do • Own study document collection/tracking (CVs, 1572s, IRB approvals, lab certs, contracts, protocols, etc.)., • Set up/maintain/close out TMF/eTMF; run QC and fix discrepancies., • Maintain core study trackers/metrics (contacts, vendor lists, visit reports, monitoring visit tracking, samples, supplies)., • Build agendas and capture clean, actionable meeting minutes (internal + external)., • Support investigator meetings, monitor workshops, and study manuals., • Coordinate document workflows with Regulatory Affairs to hit submission timelines., • Support data reconciliation and help with database/listing review as assigned., • Maintain clinical trial public postings (e.g., ClinicalTrials.gov, EU registries)., • Support clinical trial insurance documentation and renewals. What they’re looking for • Bachelor’s degree (science or related)., • 2+ years of clinical trial operations experience in biotech/pharma (sponsor experience preferred)., • eTMF experience (filing, QC, and inspection readiness mindset)., • Sharp organization, high attention to detail, and comfort juggling priorities., • Strong communication skills with study teams, sites, and vendors., • Microsoft Office proficiency., • Travel up to ~20%. Compensation • Target contract pay rate: up to $60~$70/hr (some flexibility).

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 RTx-015 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. Ray Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation. Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs will play a critical role in leading and executing global regulatory strategy for our clinical-stage programs. This role is ideal for someone who thrives in a fast-paced biotech environment and can operate both strategically and tactically. The Director will play a key role in advancing our pipeline through clinical development and preparing for future regulatory submissions. Key Responsibilities include but are not limited to: • Develop and execute global regulatory strategies for assigned programs (IND through late-stage development)., • Lead preparation, submission, and maintenance of regulatory filings including INDs, CTAs, amendments, annual reports, and briefing documents., • Leading Regulatory Agency meeting preparation and participation., • Provide regulatory guidance to cross-functional teams (clinical, CMC, nonclinical, quality) to ensure alignment with regulatory requirements and timelines., • Oversee and contribute to the authoring and review of regulatory documents (e.g., protocols, investigator brochures, clinical study reports)., • Monitor and interpret evolving regulatory requirements and communicate implications to internal stakeholders., • Support planning and execution of key milestones such as End-of-Phase meetings and pre-NDA/BLA interactions., • Manage external regulatory consultants and vendors as needed., • Ensure inspection readiness and compliance with applicable regulations and guidelines. Qualifications: • Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred., • ~8–12+ years of regulatory affairs experience in biotech/pharma., • Strong experience with INDs and early-to-mid stage clinical development; experience with late-stage or NDA/BLA submissions is a plus., • Working knowledge of FDA regulations and ICH guidelines; global regulatory experience preferred., • Demonstrated ability to work cross-functionally and influence without authority., • Strong writing, communication, and organizational skills., • Ability to operate independently and adapt in a small company environment. Compensation Range and Benefits: • The anticipated base salary range is 200-235K, and will be 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. Search Firm Representatives Please Read Carefully Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.

Ray Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation. We are currently seeking a highly motivated and detail-oriented VP of Quality and Compliance to join our team in the mission to restore vision to patients. This role will report to the Chief Development Officer The selected candidate will work closely with our Clinical and CMC teams and establish the Quality Department. The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and/or Quality Control functions. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and will require 15-20% domestic travel to our contract development and manufacturing organizations in the United States. Position Overview: The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and Quality Control functions. They are responsible for leading all quality control systems, regulatory compliance, and safety, ensuring products/services meet industry standards. They are responsible for clinical and CMC quality requirements, vendor management, internal and external compliance, and ensuring that AAV drug substance and product manufacturing, testing, and release meet FDA, EMA, and ICH regulatory standards, from clinical stage to commercialization. The Vice President of Quality will establish, lead and develop the quality function, in line with the company's stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment. Essential Duties and Responsibilities: • Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical CROs and CMC CDMO’s, • Maintain efficient systems and processes that ensure RayTx and its vendor network comply with GXP standards, • Ensure the appropriate identification, evaluation, and management of risks associated with quality, • Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations, • Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle, • Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues, • Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations, • Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP activities, • Prior experience establishing a Quality Department and growing a group., • Strong knowledge and understanding of clinical trial design., • Quality Management System (QMS) Oversight: Develop, implement, and maintain robust quality systems, including document control, change control, deviation management, and CAPA (Corrective and Preventive Actions)., • Provide expert quality oversight on AAV manufacturing processes, analytical method validations, and comparability studies., • Prior experience developing GCP / GMP auditing plans., • Regulatory Compliance: Ensure site compliance with global regulations (FDA, EMA) and lead audit readiness efforts (internal and external inspections)., • Batch Disposition: enact internal quality reviews of GMP batch records, and management of finalization and release of clinical or commercial AAV vectors., • Vendor Management: Oversee quality agreements and audits for Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CRO’s)., • Team Leadership: Mentor and lead quality personnel, fostering a culture of quality, safety, and operational excellence Qualifications and Experience: • Minimum bachelor's degree in relevant scientific or engineering discipline., • 8+ years relevant biotech experience., • Experience in GMP AAV gene therapy manufacturing preferred., • Knowledge of AAV analytical methods and testing preferred., • Experience working with CDMO, CRO’s, and other external vendors preferred., • Experience with clinical quality oversight, SOP generation, • Experience with vendor management and audit planning, • Excellent scientific knowledge and acumen., • Familiarity with regulatory requirements and documentation, • Ability to travel up to 20% Compensation Range and Benefits: • 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 annual performance-based bonus, annual equity awards 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. Search Firm Representatives Please Read Carefully Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.

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 RTx-015 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. We are currently seeking an exceptional team member to join our team as a CMC Technical Development Specialist. This role will report to the Senior Director, CMC Analytics, and will have an active role supporting the general CMC department as well as our process, product management, and MSAT teams. The position requires hands on support for AAV analytical development, transfer, and qualification through validation support for our lead candidates from Pre-IND to BLA. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and may require travel to our external vendors at in the United States. If the lab is where your curiosity comes alive and breakthroughs spark your excitement, this position may be right for you. The job duties and responsibilities include but is not limited to the following: • Collaborate with analytical development and process development teams to develop, qualify and/or validate AAV gene therapy assays., • Develop analytical methods and support method optimization/characterization., • Independently execute analytical assays including molecular biology assays, chemical/biochemical assays, and cell-based biological potency assays, for internal CMC commitments, process monitoring, release and stability., • Develop protocols for analytical transfer, qualification and /or validation studies and execute associated wetlab work., • Present aasay methodology and principles to external partners and support method transfers., • Execute routine assays with high presicion and provide data summaries and reports in a timely manner., • Document all raw data, method plans, and summarize conclusions., • Author and review Test Methods, Reports, and Protocols., • Work in the lab independently and in a collaborative environment with minimal guidance., • Support CMC outside of analytical teams to move programs forward, e.g. shelf-life determination, upstream characterization etc. Qualifications and Experience: • BA/BS in Biochemistry, Biology, bioengineering or a related fields and at least 10 years of Biotech/pharmaceutical industry experienced required., • Experienced in compendial methods, CE-SDS, gel electrophoresis, HPLC, DLS, ddPCR or qPCR, ELISA, and cell based potency assays., • Hands on experience in AAV gene therapy analytical methods and testing required., • Experience in precision pipetting and cell culture (handling, aseptic techniques, maintenance), plate-based imaging, ELISAs, luminescence and fluorescence detection techniques., • Curiosity and good scientific knowledge and acumen. Compensation Range and Benefits: • For this role, the anticipated base salary range: $145,000 to $160,000, 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 annual performance-based bonus, annual equity awards 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. Search Firm Representatives Please Read Carefully Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.

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