n-Lorem Foundation · 19 hours ago
Preclinical Scientist (Study Monitor / Toxicology)
San Diego, CA
Full-time
Hybrid
Mid, Senior Level
$90K/yr - $120K/yr
3+ years expn-Lorem Foundation is a pioneering non-profit biotechnology company focused on providing personalized experimental ASO treatments for nano-rare patients. They are seeking an experienced Preclinical Scientist to oversee nonclinical study oversight and toxicology, ensuring scientific rigor and data quality while managing multiple studies in a fast-paced environment.
Health CareNon ProfitTherapeutics
Responsibilities
Serve as scientific lead and primary study monitor for assigned nonclinical programs, with accountability for study conduct, data quality, and scientific interpretation
Review and approve study protocols, amendments, deviations, and reports ensuring alignment with program objectives and regulatory expectations
Critically evaluate toxicology data to support go/no-go decisions and program progression
Identify risks early and proactively propose mitigation strategies, including study redesign, sequencing changes, or additional exploratory work
Author or co-author nonclinical sections of INDs, amendments, briefing documents, and responses to regulatory questions, in collaboration with the cross functional team, as needed
Oversee CRO performance, including scientific quality, timelines, and budget adherence; escalate issues as needed and drive resolution
Participate in CRO selection and scope definition, including review of proposals and scientific alignment
Ensure studies are conducted in compliance with applicable GLP or non-GLP standards, internal SOPs, and sponsor expectations
Maintain accurate study tracking and documentation, including timelines, budgets, study status, and deliverables
Ensure data integrity, archiving, and traceability of study materials and reports
Contribute to continuous improvement of internal processes, templates, and best practices for preclinical development
Qualification
Required
MS or Ph.D. in Biology, Biotechnology, Toxicology, Veterinary Medicine or closely related field, with 3 + years of experience working in a pharmaceutical, biotech or CRO
Demonstrated experience acting as a study monitor for in vivo nonclinical studies, including toxicology and/or safety studies
Comfortable working with incomplete datasets and making scientifically sound recommendations under time pressure
Strong documentation discipline, with attention to traceability and version control
High degree of personal accountability and ownership for assigned programs
Ability to independently manage multiple studies and priorities with minimal oversight
Comfort interfacing with senior internal stakeholders and external partners, including CRO scientific leadership
Ability to respectfully challenge assumptions and data quality, including with external vendors
Adaptability and resilience in a fast-moving, mission-driven environment
Strong sense of urgency balanced with scientific rigor
Collaborative mindset with the ability to work across functions and disciplines
Preferred
Experience with antisense oligonucleotides (ASOs)
Working knowledge of FDA nonclinical expectations for rare disease or individualized therapeutics
Experience supporting IND-enabling programs
Benefits
Medical
Dental
Vision
403(b)
Four weeks paid vacation
Paid sick time
Life insurance
Employee assistance program
Company
n-Lorem Foundation
N-lorem foundation focuses on creating individual treatment for patients with ultra-rare diseases caused by genetic mutations.
11-50 employees
H1B Sponsorship
n-Lorem Foundation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)
Funding
Current Stage
Early StageTotal Funding
$1MKey Investors
Solve FSHD
2022-09-13Grant· $1M
Leadership Team
Stanley Crooke
Founder and CEO
Recent News
2026-01-13
Company data provided by crunchbase