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

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

About Us

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co‑founders have reunited after leading Myo Kardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.

We have a cutting‑edge discovery and translational research platform, a pipeline of late‑stage candidates, and an industry‑leading team that is driven to improve the lives of patients.

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 non‑clinical 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.
• Draft study protocols and peer review 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 non‑clinical 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 collaborators.
• 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‑omics 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 Operating Procedures (SOPs).

Qualifications and Preferred Skills

• DVM, MD and/or PhD in a relevant discipline, with a minimum of 10+ years of non‑clinical development experience in the CRO and/or…