Position Summary

We are seeking an experienced, versatile, and detail-oriented Principal Scientist to lead nonclinical strategy across the entire lifecycle of Lipovectra’s proprietary mRNA-LNP therapeutic platform. The role spans the full arc from early exploratory non-GLP research to IND-enabling packages — owning the overall nonclinical development strategy for MLT-001 and future mRNA-LNP programs, including species selection, dose selection, study sequencing, safety margins, toxicology endpoints, recovery design, TK/PK integration and regulatory positioning.

The incumbent will serve as a strategic partner to Discovery and Formulation teams and the official GLP Sponsor Study Monitor. A key focus of this position includes evaluating mRNA-LNP asset efficacy, safety and tolerability in specialized rodent models—specifically Diet-Induced Obesity (DIO) and custom/genetically engineered mouse models (GEMMs) for metabolic and target-driven pipeline expansion—while seamlessly advancing lead programs into definitive GLP repeat-dose studies in minipigs.

Key Responsibilities

1. Exploratory Non-GLP Toxicology & Pipeline Expansion

a. Early Candidate Screening: Design and manage non-GLP exploratory efficacy, safety, dose-range finding (DRF), pilot tolerability, and dose-escalation studies (in vitro and in vivo) to support early platform decision-making.

b. Specialized Mouse Model Strategy: Oversee non-GLP efficacy and safety assessments in complex, disease-relevant rodent models, leveraging DIO mice and custom/transgenic/GEMMs to assess target-mediated liabilities, tissue delivery, lipid accumulation, and metabolic profile interactions.

c. Indication & Platform Expansion: Partner closely with Discovery Biology, Chemistry, and Formulation Science to evaluate nonclinical efficacy and safety profiles for new therapeutic indications, organ-targeted delivery systems, and novel formulations. Drive alignment with internal platform scientists and external Contract Research Organizations (CRO) contacts on test article specifications, biospecimen collection and processing, biospecimen shipping & logistics, and analytical study design.

d. Mechanistic Toxicity: Investigate platform-specific liabilities (e.g., innate immune/cytokine response, off-target organ accumulation, complement activation [CARPA], metabolic perturbance, and repeated-dosing tolerability) to establish early safety margins.

e. Route & Delivery Exploration: Evaluate nonclinical delivery profiles with a primary focus on localized administration, target adipose tissue exposure, systemic exposure, and tissue biodistribution; experience exploring alternative routes (e.g., IV, IM, intratracheal, intrathecal) across exploratory animal models to broaden platform utility is desirable.

2. GLP Study Oversight, CRO Operations, & Regulatory Monitoring

a. Sponsor Study Monitor: Serve as the primary technical and regulatory contact overseeing outsourced GLP repeat-dose toxicology, safety pharmacology, developmental/reproductive toxicity (DART), and genotoxicity studies at CROs. Own end-to-end execution of external in vivo and ex vivo study packages, including study tracking infrastructure, test article logistics, biospecimen logistics, and timeline governance across CRO partners. Travel to CRO partners for in-person oversight of critical portions of studies.

b. Minipig Platform Expertise: Lead the strategic selection, dosing protocol development, toxicokinetic (TK) assessment, and histopathology review for GLP studies in minipig models (Gottingen, Yucatan, or Hanford).

c. CRO Management & On-Site Audit: Direct study initiation, protocol writing, live-phase monitoring, necropsy inspections, and final report sign-offs while ensuring strict adherence to FDA 21 CFR Part 58 and OECD GLP guidelines.

d. Sample Integrity & Chain-of-Custody Governance: Establish and own end-to-end sample lifecycle management and chain-of-custody standards for biological matrices (primary tissues, animal organs, plasma, and cell lysates), including cataloging systems, storage conditions, and domestic/international shipping logistics spanning clinical donor sites, external CROs, and internal laboratories.

e. Data Standards & Protocol Governance: Author, update, and review experimental protocols to embed FDA-compliant data requirements (e.g., CDISC SEND, 21 CFR Part 11) across nonclinical GLP toxicity and IND-enabling studies, setting the standard for regulatory-ready data capture from study initiation.

3. Cross-Functional Leadership & Regulatory Submissions

a. Nonclinical Safety Lead: Serve on cross-functional pipeline teams, integrating safety data with pharmacology, pharmacokinetics (PK), and clinical development strategy.

b. Regulatory Authoring & Engagement: Author and review nonclinical safety summaries for global regulatory submissions, including IND, CTA, IMPD, and Investigator's Brochure (specifically eCTD Module 4). Engage with regulatory authorities (FDA, EMA, etc.) during pre-IND meetings and respond to agency queries regarding nonclinical safety packages.

Required Qualifications
• Education: Ph.D. in Toxicology, Pharmacology, Pathology, Veterinary Medicine (D.V.M.), or a related life sciences field OR M.S. in Toxicology/Pharmacology with 7+ years of pharmaceutical/biotech industry experience spanning discovery through GLP toxicology.
• 7–10+ years of pharmaceutical/biotech industry experience in nonclinical safety assessment.
• Proven track record across both non-GLP exploratory/discovery toxicology (pipeline de-risking) and GLP regulatory toxicology.
• In-depth scientific knowledge of mRNA therapeutics, LNP formulations, and platform-associated toxicities.
• Experience with interpreting biodistribution / tissue exposure data for nucleic-acid therapeutics and/or LNPs.
• Hands-on experience working with minipig or non-rodent large animal models, including tailored dosing, clinical pathology, and tissue collection protocols, with deep command of standard in vivo study execution — dosing routes, sampling schedules, necropsy procedures — and downstream biological sample processing workflows.
• Extensive experience serving as a Sponsor Study Monitor managing CROs, protocol amendments, and GLP compliance audits, including acting as the primary operational and scientific point of contact for CROs, central labs, and clinical collection partners.
• Demonstrated experience establishing and overseeing biological specimen inventory and chain-of-custody systems, including LIMS implementation and cold-chain shipping protocols across multi-site study networks.
• Mastery of global nonclinical guidelines (FDA 21 CFR Part 58, OECD GLP, ICH M3(R2), ICH S6, ICH S9).

Preferred Qualifications
• DABT (Diplomate of the American Board of Toxicology) certification
• Prior experience managing test articles or biological samples derived from nucleic acid therapeutics, LNPs, or novel delivery platforms.
• Hands-on or oversight experience using DIO rodent models and custom/transgenic/ GEMMs to evaluate safety, target-mediated effects, and metabolic parameters.

· Experience with 3D culture systems, including patient-derived organoids.
• Experience in oncology.

Professional Competencies
• Analytical Problem-Solving: Strong analytical and critical-thinking skills to investigate mechanistic liabilities, troubleshoot complex study issues, and resolve technical challenges.
• Communication: Advanced technical writing and presentation skills, with the ability to convey complex scientific data clearly to regulatory authorities, cross-functional teams, and corporate stakeholders.
• Autonomy & Agility: Proven ability to self-direct and manage multiple concurrent programs in a fast-paced, matrixed startup environment without relying on layered support staff.

Compensation

Salary: $175,000 – $225,000*
• Final compensation depends on candidate location, level of experience, and DABT board certification.

Equal Opportunity Employer

Lipovectra Inc. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, age, or any other status protected by applicable laws and regulations.