Director, Non-Clinical Development & Translational Sciences
Listed on 2026-02-01
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Healthcare
Healthcare Administration, Healthcare Management
Director, 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 Giannakakos, Jay Edelberg, M.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.
Values:
Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic – leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds.
We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.
Position Title: Director, Non-Clinical Development & Translational Sciences
Department: Translational Sciences
Reports To: VP, Research & Translational Sciences
Location: South San Francisco, CA – On-site 4 days per week (Mon to Thurs)
The Director of Non-Clinical Development, under the umbrella of Translational Sciences, 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 all aspects of non-clinical development at Kardigan
- Design, execute, and oversee the in vitro/in vivo 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 development programs.
- 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
- 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…
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