Associate Director/Director of Preclinical Development

1w1 week ago

Kernal Bio

Boston, US · Full-time · $250,000 – $350,000

About this role

Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, it advances precision treatments for autoimmune diseases and blood cancers. The company seeks an experienced leader with deep expertise in immunology to lead preclinical development activities, reporting to the Vice President of R&D.

This role guides the company’s preclinical immunology efforts for mRNA therapeutics, including designing, executing, and analyzing pharmacology, toxicology, and DMPK studies for in vivo CAR-T programs. The leader will manage CROs, plan timelines and budgets, and oversee risk mitigation. Responsibilities extend to preparing technical reports and leading regulatory filings with FDA, EMA, and TGA.

Work closely with internal teams in computational biology and mRNA delivery, plus external collaborators, funding agencies, and SAB members. Thrive in a fast-paced, dynamic startup environment as an inspirational leader and team player. Collaborate with experts from MIT, Harvard, Merck, and BMS, backed by Hummingbird Ventures, Amgen, Lilly, HBM, ARPA-H, and NVIDIA.

Develop TPPs and revise them based on data and landscape analysis, while staying current on scientific literature and patents. Present preclinical updates internally and externally to drive company goals. Transform the future of cell therapy design and delivery with a proven track record in drug development.

Requirements

Ph.D. or M.D./Ph.D. in toxicology, pharmacology, immunology, immuno-oncology, genetics, or a related field, with 7+ years of Biotech/Pharma experience and 3+ years in managerial roles
Comprehensive knowledge of preclinical development in autoimmune diseases, with preferred familiarity with immuno-oncology (e.g., CAR-T)
Expertise in state-of-the-art methods for exploring cancer cell–immune cell interactions and assay development for mechanistic characterization of development candidates
Proven track record of scientific accomplishments, demonstrated by publications, patent applications, and key contributions to Go/No-Go decisions
Hands-on experience with multi-parameter flow cytometry, qPCR, and Western blotting
Familiarity with single-cell sorting and deep immune profiling (including multiplex approaches)
Experience collaborating with the FDA and other regulatory agencies (e.g., TGA) for preclinical and clinical development of autoimmune disease programs
Extensive experience authoring key regulatory filings (e.g., IND/HREC submissions) and leading meetings with regulatory agencies

Responsibilities

Guide company’s preclinical immunology efforts for mRNA 2.0 therapeutics
Design, execute, oversee, and analyze preclinical pharmacology, toxicology, DMPK studies for in vivo CAR-T programs
Work collaboratively with internal and external cross-functional teams, collaborators, funding agencies, and SAB members to align, plan and execute research and development plans
Stay up-to-date on scientific literature and patent landscape and prepare technical reports and white papers
Lead regulatory filings with agencies, including FDA, EMA, and TGA
Manage CROs and collaborate with academic/industry partners for external preclinical studies
Plan and oversee timelines, budgets, and risk mitigation for preclinical programs
Prepare and present preclinical program updates internally and externally