Director / Senior Director, Preclinical Research & Development

Company Description

We are a privately held, stealth-mode start-up biotechnology company developing lipid nanoparticle based approaches to address unmet medical needs across oncology, hematology, and neuroscience.

The Role

We are seeking a Director / Senior Director, Preclinical Research & Development to own the preclinical engine behind our mRNA-tLNP programs across multiple sites. Reporting to the CTO, this person will run preclinical research operations across our research sites, covering in vitro screening and in vivo pharmacology that support candidate nomination, and will carry the departmental budget, the quarterly goals, and the external partnerships that deliver them. This is a hands-on leadership role in a small company: the person who decides which experiments get run, what they cost, and whether the data supports advancing a candidate.

Roles and Responsibilities of the Position

• Own preclinical strategy and execution across all sites for mRNA-tLNP programs spanning in vitro screening, rodent efficacy, biodistribution and tolerability, through to PK/PD and dose range finding.


• Lead candidate nomination: define the efficacy, safety, and tolerability criteria, assemble the data package, and make the recommendation to leadership. Own the evidence base that gates GLP toxicology, the Pre-IND meeting, and the IND filing.


• Build and own the departmental budget across all sites: cost per experiment, quarterly phasing, capital equipment planning and depreciation, and the trade-offs between study count, study size, and program risk. Present and defend the annual request to executive leadership and the board.


• Set and track quarterly departmental goals by site and by project; translate program timelines into resourced, measurable commitments and report progress against them.


• Own preclinical program delivery with CRO partners, covering study design (group size, dosing schedule, necropsy and recovery phases, collection schedule), bioanalysis panel design, animal sourcing and allocation in a constrained supply market, and the transition from exploratory studies to GLP toxicology.


• Own potency assay strategy, including in-house assay development and qualification, and technology transfer of potency assays to external CROs in support of GMP release testing.


• Build, hire, and lead multidisciplinary teams across multiple sites internationally and across time zones, including a new site build-out; manage matrixed contributors and external site partnerships.


• Select, qualify, negotiate with, and manage CROs and vendors across geographies, spanning in vivo pharmacology, antibody engineering, specificity screening, non-human primate toxicology, and analytical services, and own the quality of the data that comes back.


• Evaluate in-licensing and partnership opportunities: design and run the screening of partner material under MTA, and deliver the technical diligence that supports term-sheet decisions.


• Partner across functions, including formulation, drug substance, analytical development, CMC, project management, and regulatory, to align preclinical data generation with manufacturing and filing timelines.


• Communicate complex preclinical datasets, budgets, and program risk to internal leadership, the board, investors, and external partners through well-constructed reports, slide decks, and working sessions.

Required Qualifications

• PhD in immunology, molecular biology, pharmacology, bioengineering, or a related discipline. Final level (Director or Senior Director) will be determined based on experience and scope.


• Minimum 8 years of preclinical drug development experience, with progressive leadership responsibility and direct ownership of program-level decisions.


• Demonstrated CAR-T industry experience, including in vivo pharmacology and the data package that supports candidate nomination.


• Proven experience designing and overseeing in vivo studies and PK/PD or toxicology studies run through CRO partners.


• Track record of owning a departmental or program budget, including capital planning, vendor negotiation, and defending a funding request to executive leadership.


• Experience selecting and managing CROs across multiple geographies, including international partners.


• Experience with analytical or potency assay development, qualification, and technology transfer to an external testing site.


• Experience hiring, mentoring, and scaling teams, with comfort operating in a small company without large support functions.


• Full working proficiency in English, with clear and concise communication, able to present to the board and to investors and to write for both technical and non-technical audiences.

Additional Preferences

• Experience with LNP or other targeted delivery systems and ligand-directed delivery.


• Direct experience with in vivo CAR. Background in autoimmune and immunology CAR-T applications, in addition to oncology.


• Working knowledge of gene therapy development and CNS field


• IND-enabling experience for novel nucleic acid or cell therapy modalities, including GLP toxicology study design and FDA interactions.


• Experience building or scaling a preclinical research site, including equipment selection,


• Track record of publications, issued patents, or contributions to INDs in CAR-T, mRNA, or gene editing, and CNS space.


• A bias toward proactive problem-solving and a collaborative mindset suited to a small, high-velocity team.

Location

San Diego, CA. This is an on-site position, with regular international travel.

What We Offer

• An opportunity to work at the forefront of RNA and LNP-based therapeutic innovation


• A collaborative, science-first culture where individual contributions are visible and impactful


• Competitive compensation and benefits package, including health, dental, vision, and life insurance


• 401(k) with company match