Senior Director, Nonclinical Development and Translational Science

Character Biosciences is a drug discovery and development company building world-class, deeply-phenotyped databases that integrate genomics with longitudinal clinical and imaging data. Our interdisciplinary team, comprising experts in clinical science, data science, statistical genetics, machine learning and drug discovery, utilizes this platform to determine genetic drivers of disease progression, advance novel therapeutics and define genetics-based patient stratification. Powered by our data platform, Character Bio is currently advancing two programs in Dry Age-related Macular Degeneration with additional programs in earlier stages of discovery research.

As our Sr Director, Nonclinical Development and Translational Science, you will play a pivotal role in shaping Character’s nonclinical development and translational science strategy. Reporting directly to our Chief Scientific Officer, you will lead key initiatives across toxicology, pharmacology, and biomarker strategy while collaborating closely with cross-functional teams to drive our therapeutic programs forward. Note: this is a remote/hybrid role with occasional travel required to Character Biosciences site(s) in South San Francisco, San Diego or Jersey City.

Key Responsibilities:

• Oversee vendor selection and study management for translational pharmacology studies, Pharmacokinetics, non-GLP, and GLP studies

• Develop translational biomarker strategies for late stage pre-clinical programs and operationalize these strategies in non-clinical and clinical studies

• Extend the capabilities of research team through use of innovative human model systems (eg organoids)

• Serve as a member of clinical development teams, representing toxicology and translational science functions; co-lead the non-clinical subteam with the research project lead

• Lead and contribute to research project core teams, driving scientific strategy and execution

• Collaborate with Research Lead(s) to plan, execute, and analyze in vivo pharmacology, Pharmacokinetics, non-GLP, and GLP studies

• Track deliverables, timelines and budgets to ensure successful project execution.

• Collaborate cross functionally with data scientists, clinical researchers, and senior leadership to integrate translational science into drug development strategies

Key Qualifications:

• 8+ years of experience in nonclinical development/toxicology and translational science, including 3+ years in a leadership role

• PhD in Pharmacology, Toxicology, or a related discipline

• Deep expertise in in vivo pharmacology, pharmacokinetics (PK), and non GLP/GLP study design and execution. 

• Experience developing biomarker strategies and translating from pre-clinical to clinical 

• Detailed understanding of the full drug development process, from discovery through clinical stages including significant experience supporting clinical development.

• Prior experience in ophthalmology drug discovery and development is highly desirable

• Demonstrated experience leading complex, cross-functional projects with successful outcomes

• Strong collaborator capable of leading teams and participating on teams

• Excellent analytical, problem solving, and strategic planning skills.