Senior Medical Director/Medical Director, Clinical Trial Lead

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. Position Title: Senior Director / Medical Director – Clinical Trial Lead Department: Clinical Development Reports To: Vice President, Clinical Development Lead Location: South San Francisco, CA or Princeton, NJ – On-site 3-4 days per week Job Overview The Senior Director / Medical Director - Clinical Trial Lead will be a physician with extensive drug development expertise who will be expected to lead to the clinical development strategy for the phase 1-3 clinical trials of the program, including the protocol design, operational planning and trial execution, medical and safety monitoring, trial close out, trial results interpretation, and preparation for dissemination of the trial results, working with academic partners. Essential Duties and Responsibilities Leads the aforementioned clinical activities for the phase 1-3 trials for the program as a key member of the Clinical Strategy Team, that is embedded within the Global Project Team, including taking primary responsibility for medical monitoring, data monitoring, and safety monitoring for the clinical development function Provide clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence generation plan, working closely with Medical Affairs colleagues Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program Takes primary responsibility for the clinical development function, working with statisticians, modelers, and project team-members, for contributing to the creation of trial-specific statistical analysis plans, and for the interpretation, reporting, and dissemination of the final results, working closely with academic partners Contributes to and provides oversight of the operational aspects of study conduct including site selection and activation, site investigator and staff training, site start up and activation, screening and recruitment of trial participants, and trial close-out activities Leads the authoring and review of clinical parts of regulatory submissions, regulatory briefing documents, Investigational Brochures, scientific disclosures of trial results, and other relevant documents. Leads clinical responses to regulatory or IRB/Research Ethics Committee for inf…