Director, Preclinical Development
About The Position
Addition Therapeutics is seeking a highly skilled and motivated Director, Preclinical Development to join our Preclinical Translation Team and provide scientific leadership for the advancement of our novel PRINT™ platform and therapeutic programs toward the clinic. This individual will lead the development and execution of integrated preclinical strategies across programs, from early proof-of-concept and candidate optimization through IND-enabling activities. The successful candidate will provide scientific leadership across preclinical development with particular emphasis on in vivo pharmacology and translation to NHPs. Depending on experience and organizational needs, the individual may also provide leadership for early nonclinical safety assessment and integration of safety findings into program strategy, while partnering with external toxicology experts and CROs for formal toxicology activities. A critical component of this role will be the integration of in vivo pharmacology with bioanalytical, PK/PD, biodistribution, tissue biology, histopathology, and early safety readouts to build a coherent translational understanding of the therapeutic. The ideal candidate is a scientifically rigorous and highly collaborative drug developer with strong strategic judgment, operational discipline, and the ability to lead through influence in a fast-paced, matrixed organization. This role offers a unique opportunity to shape the nonclinical development strategy for a novel genetic medicine platform and to establish the translational foundation for therapies based on permanent gene insertion.
Requirements
- M.S. or Ph.D. in Biology, Pharmacology, Toxicology, or a related discipline with 10+ years of relevant industry experience.
- Strong track record of leading in vivo pharmacology and preclinical development programs, including substantial direct experience planning and executing NHP studies.
- Demonstrated ability to translate scientific and program objectives into hypothesis-driven, fit-for-purpose in vivo studies that address key program questions and enable clear development decisions.
- Strong experience in managing external CROs and integrating complex preclinical datasets to interpret study outcomes and inform key decisions.
- Experience supporting IND-enabling programs and preparation of regulatory submissions.
- Excellent organizational and project management skills, with meticulous attention to detail and the ability to manage multiple studies, programs, CROs, and competing priorities.
- Demonstrated ability to work collaboratively across functions and influence program decisions through strong scientific judgment and clear communication.
- Resourceful, adaptable, and highly motivated, with a strong sense of ownership and commitment to scientific rigor and operational excellence in a fast-paced environment.
Nice To Haves
- Experience with early nonclinical safety assessment and/or working closely with toxicology teams is preferred.
- Direct experience developing and/or utilizing animal models in obesity/metabolic disease and/or in vivo CAR-T therapy is highly desirable; demonstrated expertise in either area would be a significant advantage.
- Experience with genetic medicines, RNA-based therapeutics, RNA-LNPs, gene delivery technologies, cell therapies, or other complex biological modalities is strongly preferred.
Responsibilities
- Develop and implement integrated preclinical strategies to support PRINT™ platform development, target validation, therapeutic program advancement, and IND-enabling activities.
- Provide scientific leadership for in vivo rodent and NHP studies including appropriate models, controls, dose levels, timepoints, endpoints, and tissue collections.
- Integrate in vivo pharmacology with PK/PD, bioanalytical, molecular, biodistribution, histopathology, tissue biology, and other translational readouts to establish relationships between exposure, mechanism, pharmacodynamic activity, efficacy, durability, and safety.
- Provide scientific oversight of early nonclinical safety assessments and contribute to development of an integrated safety strategy, including interpretation of immune-related findings, histopathology, and other safety signals.
- Manage external CROs and other vendors across the full study lifecycle, including vendor selection, scope and protocol development, study initiation, ongoing study oversight, troubleshooting, data review, interpretation, and final reporting.
- Serve as a scientific leader in cross-functional program teams, working closely with Platform Research, Program, Bioanalytical Sciences, Histopathology, CMC/Formulation, and other functions to align preclinical strategy with program milestones.
- Establish and maintain efficient operational processes, systems, and documentation standards to support study execution, data integrity, traceability, and regulatory-filing-ready reporting.
- Mentor and develop scientists within the Preclinical Translation organization and contribute to building a high-performing culture of scientific rigor, collaboration, accountability, and operational excellence.
Benefits
- Equal Opportunity employer
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What This Job Offers
Job Type
Full-time
Career Level
Director
