Regulatory Strategy

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 MyoKardia 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.   At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. 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.   These values are the foundation of our work, empowering us to make a real difference, every day.    

About the Team
Kardigan’s Regulatory Affairs team is a collaborative and strategic partner in advancing our portfolio of investigational cardiovascular therapies. Working closely with colleagues across Clinical Development, Medical Affairs, Safety, CMC, Quality and other functions, the team translates evolving science and development plans into clear regulatory strategies that support high-quality decisions and productive engagement with global health authorities.

We are building a team that combines scientific rigor, sound judgment, and a practical, solutions-oriented mindset. Team members have the opportunity to shape regulatory approaches, establish scalable ways of working, and influence programs at important stages of development. Our work helps Kardigan move with urgency while maintaining the highest standards of quality, ethics, and compliance, ultimately supporting our mission to bring potentially transformative treatments to people living with cardiovascular disease.

Job Overview
Kardigan is seeking an Executive Director, Regulatory Strategy to lead global regulatory strategy across our portfolio of investigational cardiovascular therapies. Reporting to the SVP, Regulatory Affairs, this leader will serve as the regulatory lead on program teams, own the development and execution of regulatory strategy in line with the integrated development plan for late-stage clinical programs, and act as the primary interface with the U.S. Food and Drug Administration while directing ex-US regulatory activities with support from consultants, vendors, and partners.