Kernalbio
Associate Director/Director of Preclinical Development
Boston, MA · Director
Sponsorship not specifiedDetected 148 days ago
Intellectual PropertyPharmacologyFDA RegulatoryBioinformaticsqPCRFlow CytometryResearchAnimal StudiesLeadershipCommunication
About the role
- This person will report to the Vice President of R&D and will be responsible for leading preclinical development activities in immunology.
- In addition, this person will work closely with computational biology and mRNA delivery leadership to execute on company goals.
- Ideal candidate will be an inspirational leader and a great team player with a proven track record in drug development, excellent communication skills, and effective management style.
Responsibilities
- Independently design, execute, oversee, and analyze preclinical pharmacology, toxicology, DMPK studies for in vivo CAR-T programs.
- Lead regulatory filings with agencies, including FDA, EMA, and TGA.
- Manage CROs and collaborate with academic/industry partners for external preclinical studies
- Develop TPPs and periodically revise them in response to internal data generation and ongoing landscape analysis.
- 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, Kernal Bio is advancing precision treatments for autoimmune diseases and blood cancers.
- Kernal Bio is transforming the future of cell therapy design and delivery.
Requirements
- 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.
- Proven success in managing scientists and associates effectively.
Nice to have
- Prior experience with mRNA LNPs and in vivo CAR-T therapies.
- Comprehensive knowledge of preclinical development in autoimmune diseases, with preferred familiarity with immuno-oncology (e.g., CAR-T).
Compensation
- Competitive vacation and sick days per year
Benefits
- Highly competitive healthcare coverage (PPO/HMO)
- Free parking, monthly subway pass, or a subsidized commuter rail pass
- Gym Membership Support
- Flexible Spending Account
- Paid parental leave, family caregiver leave, medical leave
- Paid life insurance coverage
- Competitive vacation and sick days per year
- We do not discriminate in employment practices for the race, color, national origin, age, gender, sexual orientation, marital or veteran status, religion, disability, or any other legally protected status.
Company info
- The company was founded by experts from MIT, Harvard, Merck, and BMS, and its leadership team brings a track record of three FDA-approved therapies and over 120 patents.
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