Nonclinical Study Manager

Who We Are:Osanni Bio is a development-stage therapeutics platform, headquartered in San Francisco, California. We are creative and agile innovators, relentlessly curious about finding new ways to target the biology behind diseases with the greatest unmet need and determined to do something about it.At the center of Osanni is its innovation engine, which is optimized for discovering new scientific insights, designing novel drug concepts, and efficiently advancing programs to a meaningful proof-of-concept. Once a program is sufficiently de-risked, it graduates into its ecosystem of affiliate companies, which are equipped with the dedicated focus, specialized talent and support necessary to scale. Osanni's architecture marries the scientific depth and operational power of a centralized platform with the speed, agility and accountability of independent companies. The result: an opportunity to create and deliver more transformative medicines.We hold patients and the physicians who care for them as our North Star. It guides our purpose, sharpens our decision-making, and defines our impact. Osanni is currently advancing programs in ophthalmology, cardiology and beyond. We are building a highly skilled team, passionate about having an impact on human health. Be part of creating an organization where people enjoy their work and their colleagues, are valued for their individuality, and can't imagine working anywhere else.This role is based in our San Carlos location, on-site 2-3 days per week.About the RoleThe Nonclinical Study Monitor and Manager is responsible for sponsor-side monitoring and operational management of outsourced and selected in-house nonclinical studies supporting Osanni’s research and development programs. Reporting directly to the Director of Nonclinical Development, this role coordinates studies from planning and CRO selection through protocol development, in-life execution, data review, and final reporting.The role has a particular focus on CRO study execution, animal husbandry, animal welfare, and the quality and completeness of in-life data. The individual will work closely with CRO Study Directors, veterinarians, husbandry teams, technical operations, ophthalmologists, pathologists, and other contributing scientists to ensure that studies are conducted in accordance with protocols, SOPs, GLP requirements, applicable animal welfare standards, and Osanni’s scientific objectives.The ideal candidate brings extensive hands-on experience in a nonclinical CRO or biopharmaceutical setting, including direct involvement in animal care, husbandry, colony or vivarium operations, and technical study procedures. This individual understands how study design translates into daily animal and operational activities, recognizes emerging execution or welfare risks, and communicates them promptly. The role works both strategically and hands-on, maintaining high scientific and animal welfare standards while keeping programs moving with the accountability and collaboration Osanni expects across the Flock.What You Will DoServe as the sponsor-side monitor and manager for assigned GLP and non-GLP studies, translating program objectives into phase-appropriate study plans, designs, schedules, budgets, and operational requirements.Lead CRO identification, proposal and protocol review, study placement, initiation, routine monitoring, issue resolution, data delivery, and final report completion.Maintain frequent communication with CRO Study Directors, study supervisors, veterinarians, husbandry personnel, and technical teams to confirm study readiness, resource availability, scheduling, and completion of critical activities.Monitor animal receipt, quarantine, acclimation, assignment, housing, environmental conditions, enrichment, feeding, watering, health observations, socialization, and movement on and off study, as applicable to the protocol and species.Evaluate whether husbandry practices, facility conditions, staffing, equipment, and animal availability are appropriate for study requirements and promptly escalate conditions that may affect animal welfare, study integrity, timelines, or data interpretation.Review study designs and protocols for operational feasibility, animal welfare, IACUC alignment, pain classifications, sedation and restraint burden, sample volumes, procedure frequency, recovery intervals, and other factors affecting study animals.Monitor critical in-life phases, including test article administration, clinical observations, body weights, food consumption, sample collection, physiological measurements, ophthalmic procedures, surgery-related activities, and necropsy coordination.Provide hands-on technical support and oversight for ophthalmic procedures and endpoints, including ocular preparation, intraocular pressure measurements, electroretinography, support for ocular dosing, ocular sample collection, and other relevant ocular assessments.Review protocols, amendments, deviations, in-life records, electronic data, tables, figures, and reports for accuracy, completeness, protocol and SOP compliance, and timely documentation of changes.Ensure sponsor-requested protocol changes and amendments are communicated promptly to affected CRO functions and implemented only after appropriate review, approval, and training.Coordinate toxicology, PK/TK, bioanalytical, safety pharmacology, and related research activities across CRO departments, including formulations, clinical pathology, ophthalmology, veterinary services, necropsy, pathology, and reporting.Support interpretation of PK/TK, clinical observations, physiological data, clinical pathology, ophthalmology, and pathology findings in collaboration with the Director of Nonclinical Development and relevant subject-matter experts.Contribute to and review study reports, technical data packages, SOPs, and applicable nonclinical content for regulatory submissions and health authority responses.Provide clear, timely updates to the Director of Nonclinical Development regarding study status, animal welfare concerns, deviations, emerging findings, operational risks, timeline changes, and recommended actions.Manage multiple studies, CROs, consultants, schedules, and competing priorities while ensuring accurate and timely delivery.Travel to CROs (approximately 2-10 days per month) may be required for study initiation, monitoring, critical phases, or issue resolution.What You BringBachelor’s or Master’s degree in Pharmacology, Toxicology, Biological Sciences, Animal Science, Experimental Psychology, Veterinary Technology, or a related scientific discipline. An equivalent combination of relevant education, professional certification, and directly applicable experience will be considered.At least 10 years of relevant experience in a nonclinical CRO, biopharmaceutical company, research animal facility, or related environment.Substantial hands-on experience with laboratory animal care, husbandry, colony or vivarium operations, and in-life study execution across one or more commonly used nonclinical species.Demonstrated experience coordinating or managing GLP toxicology, pharmacokinetic, or other nonclinical studies from protocol development through study execution, data review, and reporting.Strong understanding of animal welfare and research animal care requirements, including experience working with IACUC processes and familiarity with the Animal Welfare Act, the Guide for the Care and Use of Laboratory Animals, AAALAC International expectations, and applicable USDA requirements.Working knowledge of FDA GLP regulations, study protocols, SOPs, data integrity expectations, and current nonclinical regulatory guidance.Experience overseeing CRO study operations and collaborating with Study Directors, veterinarians, husbandry teams, technical operations, and scientific support functions.Hands-on experience with ophthalmic procedures, including IOP measurements, ERG, ocular dosing support, or ocular sample collection.Experience reviewing in-life data, protocols, amendments, deviations, data tables, reports, SOPs, regulatory filings, or other technical documents.Strong organizational, project management, technical writing, and documentation skills.Strong communication skills and the ability to work effectively with interdisciplinary teams and contract laboratories.Experience with electronic study management systems such as Provantis is preferred.AALAS certification or another relevant laboratory animal science credential is preferred.The expected base pay range for this position is $125,000 - $150,000 plus bonus and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by job-related skills, experience, and relevant education or training.We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any status protected by law.We provide an intellectually stimulating, collegial, and fast-paced environment. If you are ready to help build the future of transformative medicines, we are excited to hear from you.#LI-hybrid