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Kernal Biologics is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. The company develops in vivo CAR-T therapies for autoimmune diseases and blood cancers, founded by experts from MIT, Harvard, Merck, and BMS. The company is backed by Hummingbird Ventures, Amgen, Lilly, HBM, ARPA-H, and NVIDIA.
This role leads preclinical development activities in immunology, reporting to the Senior Vice President of R&D. The successful candidate will guide the company's preclinical immunology efforts for mRNA 2.0 therapeutics and work closely with computational biology and mRNA delivery leadership.
Key responsibilities include: independently designing, executing, overseeing, and analyzing preclinical pharmacology, toxicology, and DMPK studies for in vivo CAR-T programs; collaborating with internal and external cross-functional teams, collaborators, funding agencies, and SAB members; staying current on scientific literature and patent landscape; leading regulatory filings with FDA, EMA, and TGA; managing CROs and academic/industry partnerships; planning and overseeing timelines, budgets, and risk mitigation; preparing and presenting program updates; and developing and revising Target Product Profiles (TPPs).
Required qualifications: PhD or MD/PhD in toxicology, pharmacology, immunology, immuno-oncology, genetics, or related field with 7+ years of biotech/pharma experience and 3+ years in managerial roles (5+ years of experience may qualify for Associate Director level). Comprehensive knowledge of preclinical development in autoimmune diseases with preferred familiarity with immuno-oncology and CAR-T. Expertise in state-of-the-art methods for cancer cell–immune cell interactions and assay development. Proven track record of scientific accomplishments demonstrated by publications, patents, and Go/No-Go decision contributions. Hands-on experience with flow cytometry, qPCR, Western blotting, single-cell sorting, and deep immune profiling. Experience collaborating with FDA and other regulatory agencies on preclinical and clinical development. Extensive experience authoring regulatory filings (IND/HREC submissions) and leading regulatory meetings. Strong management skills, excellent communication, and ability to maintain productive stakeholder relationships. Preferred: prior experience with mRNA LNPs and in vivo CAR-T therapies.
