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)

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.

• 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
• Hire, manage, and/or supervise a team of non-clinical scientists, consultants, and collaborator
• Serve as representative of the non-clinical function, and/or assign adequate designates, to project teams, and/or regulatory meetings
• Support the evaluation of safety assessment candidates, and the selection of development candidates
• Provide technical support to various departments within the company with respect to non-clinical development, including safety pharmacology and toxicology. Partner with relevant groups and departments to incorporate innovative technology and state-of-the art scientific knowledge/tools, including imaging, biomarkers, genetic, and multi-omic analyses (to name a few), to leverage non-clinical studies to accelerate the translational understanding of diseases and mechanisms of action for agents under development.
• Assist in the development, adherence, and optimization of departmental, project, and corporate budgets.
• Develop relevant Standard Operational Procedures (SOPs)

DVM, MD and/or PhD in a relevant discipline, with a minimum of 10+ yea