Director, Preclinical Development

Addition Therapeutics; South San Francisco (CA); On-site; USD 163,000 - 205,000; Full time

Job summary

Addition Therapeutics in South San Francisco is seeking a Director of Preclinical Development to lead integrated strategies across programs, from early proof-of-concept to IND-enabling activities. The role emphasizes in vivo pharmacology, translational readouts, and collaboration with CROs to ensure cohesive nonclinical development of the PRINT platform.

The ideal candidate has a strong track record in preclinical leadership, with experience in obesity/metabolic disease and/or cell therapy as

Qualifications

• 10+ years of relevant industry experience.
• Proven track record in leading in vivo pharmacology and preclinical development programs, incl. NHP studies.
• Experience supporting IND-enabling programs and regulatory submissions.
• Experience managing external CROs and integrating complex preclinical data.

Responsibilities

• Develop integrated preclinical strategies to support PRINT platform development and IND-enabling activities.
• Provide scientific leadership for in vivo rodent and NHP studies with appropriate models and endpoints.
• Integrate in vivo pharmacology with PK/PD, bioanalytical, tissue biology, and safety readouts.
• Oversee early nonclinical safety assessments and contribute to safety strategy.
• Manage external CROs and vendors across the study lifecycle, from scope to final reporting.
• Collaborate with cross-functional teams to align preclinical strategy with milestones.
• Establish efficient processes and documentation standards for study execution and regulatory filing.

Skills

In vivo pharmacology

NHP studies

IND-enabling programs

CRO management

translational readouts

Education

MS/PhD in Biology, Pharmacology, Toxicology

Job description

Addition Therapeutics is at the forefront of biotechnology innovation, advancing transformative therapies utilizing its proprietary PRINT™ (Precise RNA-mediated Insertion of Transgenes) platform. PRINT™ redefines genetic medicine by enabling development of RNA-only therapeutics capable of inserting any genetic element into specific safe harbor sites within the genome. Operating from state-of-the-art labs in South San Francisco, our team of experienced scientists and drug developers is leading scientific breakthroughs while cultivating a vibrant, dynamic culture committed to profoundly impacting patient lives.

Job Description

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.

Key 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.

Qualifications

• 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.
• 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.
• 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.

Compensation

The expected yearly salary for this position is $163,000-$205,000. Exact compensation may vary based on skills and experience.

Location

South San Francisco, California

We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.