Jobs and Careers

Associate Director, Digital Biomarker Lead

United Statesfull_timeVerifiedPosted 11 Aug 2026

💰 $221,000/yr($170,000/yr – $221,000/yr)

About the role

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 Overview

The Associate Director, Digital Biomarker Lead will serve as the internal strategic and digital scientist SME for digital biomarker development, owning the pathway from concept of interest through endpoint qualification. This role sits at the intersection of clinical science, translational research, and operations —bridging the CMO, Clinical Study Teams, Biostats, Medical Affairs, and Regulatory Affairs to ensure that digital endpoints are scientifically credible, operationally viable, and aligned with evolving regulatory guidance.

This individual will lead digital biomarker strategy across therapeutic programs, building the evidence base for novel digital endpoints through literature synthesis, device landscape assessment, verification and validation study design, and regulatory briefing support. The ideal candidate brings deep knowledge of digital health measurement science together with the cross-functional leadership to drive alignment across a matrixed organization.

Key Responsibilities

Serve as the primary Subject Matter Expert (SME) for digital biomarkers across the clinical development portfolio, partnering directly with the CMO, Clinical Study Teams, Medical Affairs, and Therapeutic Area leads to define digital biomarker objectives, establish Concepts of Interest (COIs), and translate them into Context of Use (COU) statements and measurement frameworks aligned with FDA DHT guidance and international regulatory standards.
Lead digital biomarker strategy for assigned programs, including support with device landscape assessment, sensor technology evaluation with Prolaio, and endpoint development roadmaps spanning early proof-of-concept through pivotal trials.
Conduct and synthesize systematic literature reviews to map aspects of health and COIs to candidate digital endpoints, characterize existing evidence on measurement properties, and identify benchmarks for meaningful change—informing both device selection and verification and validation study design.
Design and oversee verification, validation, and usability studies in collaboration with Prolaio and other device partners, ensuring that digital endpoint evidence packages meet regulatory-grade evidentiary standards.
Support the development of digital biomarker content for regulatory briefing books, and endpoint qualification submissions, and liaise with Regulatory Affairs, Biostats, Clinical Study Teams to develop qualification strategies and respond to Health Authority questions on digital measures.
Monitor and interpret evolving regulatory guidance from FDA, EMA, and other global agencies on digital health technologies, digital endpoints, advising internal stakeholders on implications for ongoing and planned programs.
Collaborate with the DHT Project Manager to ensure that digital biomarker strategy