Senior Director, Pathology/Toxicology, Non-Clinical Development & Translational Sciences

Position Title: Senior Director, Pathology/Toxicology, Non-Clinical Development & Translational Sciences 

Department: Discovery 

Reports To: VP, Discovery Research 

Location: Princeton, New Jersey or South San Francisco, CA – On-site 4 days per week (Mon to Thurs) 

Job Overview 

The Senior Director of Non-Clinical Development is a strategic role at Kardigan that will oversee the design, execution, and reporting of Kardigan’s nonclinical regulatory strategy. The incumbent will provide strategic leadership and oversight for non-clinical safety and toxicology assessments over the various stages of the drug development process from early discovery (IND planning) to late stages of clinical development up to approval. 

Essential Duties and Responsibilities 

• Oversee the development and execution of an integrated non-clinical regulatory strategy, serving as lead for key aspects of non-clinical development at Kardigan  

• Design, execute, and oversee non-clinical toxicology and safety pharmacology strategies, following (or exceeding) established guidelines/requirements. 

• In collaboration with research and development team leaders, participate in the budgeting, prioritization, staffing, and management of non-clinical programs from late discovery through early development. 

• Evaluate, select, monitor, and manage Contract Research Organizations (CROs), including risk assessment and management. 

• Drafting of study protocols, and peer review of studies and reports, until finalization, leading interpretation of data and oral/written communication of results 

• Support integrated development plans, regulatory submissions, and approvals through the timely provision of data and its analysis. Be accountable for nonclinical sections/contribution to INDs, Investigational Brochures, Regulatory Briefing Documents, and other relevant documentation for assigned programs 

• Partner with relevant members of research, discovery, CMC, quality assurance, and development to deliver program studies on time and in budget 

• In alignment with Global Program Heads, ensure consistency of non-clinical content and messages across scientific and non-scientific publications and materials