Senior Director, Clinical Operations Program 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 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.

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: Sr. Director Clinical Operations Program Lead

Department: Development

Reports To: Head of Clinical Development

Location: Princeton, New Jersey - 4 days on site (Mon-Thur)

Job Overview

Kardigan is seeking a Senior Director, Clinical Operations Program Lead for a late-stage cardiovascular asset. This position will be responsible for leading all of the activities associated with the clinical studies for the asset across all phases, including overseeing the internal operations team, CROs and vendors and working cross-functionally on the operational strategy and related initiatives. This position reports to the Head of Development Operations and serves as a member of the Development Operations Leadership team.

This position will work collaboratively across the department, the entire Kardigan portfolio and cross-functional core/project teams with the overall goal of developing new and innovative treatments for cardiovascular diseases with unmet need.

Essential Duties and Responsibilities:

• Accountable for the delivery of the assigned clinical program’s budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
• Develop and present the operational strategy and plans including supply chain to effectively execute on the Clinical Development Plan
• Partner and collaborate with cross-functional stakeholders such as the Project Team Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders
• Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Kardigan’s SOPs
• Drive the selection, oversight, and management of CROs and other vendors
• Oversee site feasibility/capability assessments in collaboration with the CRO and cross functional team
• Own the strategy and execution of creative approaches to achieve Kardigan’s corporate goals. This may…