Kernal Biologics · 18 hours ago
Associate Director/Director of Preclinical Development
Boston, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
7+ years expKernal Biologics, Inc. is a venture-backed therapeutics company focused on engineering cells inside the body using AI-designed technologies. The Director of Preclinical Development will lead the company's mRNA therapeutics efforts in immunology, overseeing preclinical development activities and collaborating with various teams to achieve research and development goals.
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
Guide company’s preclinical immunology efforts for mRNA 2.0 therapeutics
Independently 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 on the overall 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
Develop TPPs and periodically revise them in response to internal data generation and ongoing landscape analysis
Qualification
Required
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. (Candidates with 5+ years of experience may be considered for the Associate Director role)
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)
Strong passion for innovative research and a desire to make a clinical impact with mRNA therapeutics
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
Ability to maintain professional, productive relationships with internal and external stakeholders
Excellent written and verbal communication skills
Proven success in managing scientists and associates effectively
Willingness to learn, teach, and grow in a fast-paced environment
Commitment to the company's ultimate goal of serving patients
Preferred
Prior experience with mRNA LNPs and in vivo CAR-T therapies
Benefits
Competitive 401(k)
Highly competitive healthcare coverage (PPO/HMO)
Free parking, monthly subway pass, or a subsidized commuter rail pass
Free Bluebike Membership
Gym Membership Support
Flexible Spending Account
Paid parental leave, family caregiver leave, medical leave
Paid life insurance coverage
On-site cafeteria
Competitive vacation and sick days per year
Company
Kernal Biologics
Kernalbio creates mRNA therapies that instruct specific cells on how to make their own medicine.
11-50 employees
H1B Sponsorship
Kernal Biologics 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 (1)
2024 (2)
2021 (1)
Funding
Current Stage
Early StageTotal Funding
$73MKey Investors
Advanced Research Projects Agency for HealthHummingbird Ventures
2025-10-07Grant· $48M
2022-07-07Series A· $25M
2020-10-21Seed
Leadership Team
B
Burak Yilmaz
Founder & President
Recent News
Google Patent
2025-02-08
Company data provided by crunchbase