---
title: 'Director, Clinical Quality Lead at Kardigan'
canonical: 'https://feeny.ai/job/director-clinical-quality-lead-kardigan-south-san-francisco-california-united-qzg2emd2he5j'
type: 'job'
last_seen: '2026-10-17'
---

# Director, Clinical Quality Lead at Kardigan

- **Company:** Kardigan
- **Location:** South San Francisco California United States Princeton New Jersey, United States
- **Compensation:** $194k–$253k
- **Posted:** 2026-10-06
- **Last confirmed live:** 2026-10-17
- **Apply:** https://job-boards.greenhouse.io/kardigan/jobs/5442330008

## Job description

## 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.

Job Overview

The Clinical Quality Lead will play a crucial role in driving a culture of quality and ensuring that compliance is embedded throughout the R&D process.  This role will be responsible for managing GxP Quality Assurance (QA) functions and providing consultation in the interpretation of GxP regulations (GCP, GLP, GVP), guidelines, policies, and procedures.  This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate.

Essential Duties and Responsibilities

Essential duties may include the following tasks depending on level of experience

- Partners with Clinical Development/Operations and actively participates in clinical study teams to ensure GCP compliance. Reviews study-related documents and plans.
- Support and maintain the internal audit program, audit schedule, and approved vendor list.
- Performs internal and external audits as assigned to ensure compliance with GXP regulations and guidelines.
- Communicates audit results to internal stakeholders and writes audit report.
- Supports Quality Management System (QMS) including quality oversight and operational support for processes as e.g. CAPAs, audits, inspections, deviation management, risk management, change control and quality complaint handling.
- Monitor, track, and trend GxP non-conformances, deviations, CAPAs
- Leads or supports audit and inspection activities, including CAPA formulation, vendor assessments, and regulatory inspections.
- Responsible for maintaining current regulatory inspection knowledge as it relates inspections by regulatory agencies worldwide
- Interprets global legislation, regulations and guidance for development or updates to policies and standards, identify gaps and redundancies
- Leads or supports backroom activities during regulatory authority inspections and assists with GxP inspection readiness activities.
- Build and maintain cross-functional relationships to promote GxP compliance awareness throughout the R&D organization (GCP, GVP, GLP).
- Support in training initiatives on processes, new regulations and systems to enable quality compliance.
- Contribute to defining and monitoring compliance and quality metrics to ensure oversight of processes and projects and management review.

## Basic Qualifications

- Bachelor’s degree in a scientific discipline
- 7+ years in a QMS environment with proven experience in discovery, as well as non-clinical and clinical development
- Direct experience with internal/external clinical systems and process audits
- Experience in QA audits of Clinical Investigator sites and clinical vendors
- Experience in the development of SOPs
- Knowledge and experience in Good Clinical Practices (GCP)
- Strong interpersonal, negotiation, and leadership skills.
- Excellent written and verbal communication skills, with experience working in a culturally diverse, global team
- Ability to work independently and effectively prioritize tasks
- Expertise in Root Cause Analysis, CAPA development, and Risk Management methodology
- Insightful, decisive, proactive, and solutions-oriented
- Proven excellence in professional skills including communication, organization, prioritization, discretion, and accuracy
- Exceptional customer service skills, including cultivating and maintaining close working relationships with both internal and external stakeholders
- Proficiency in MS Office including Word, Excel, PowerPoint, Outlook, SharePoint, OneNote, and virtual meeting
- Available to travel as needed
- Available to be on site 4 days/week

## Preferred Qualifications

- 15+ years’ experience in the pharmaceutical or biotechnology industry with in-depth pharmaceutical QMS knowledge
- Knowledge and experience in Good Laboratory Practice (GLP, and/or Good Pharmacovigilance Practice (GVP) regulations

Exact Compensation may vary based on skills, experience and location.

Pay range $194,000—$253,000 USD

## About Kardigan

## Company Overview
- **One-liner**: Kardigan is a publicly traded biopharmaceutical company developing targeted cardiovascular therapies with the aim of transforming treatment from symptom management toward functional cures.
- **Entity Type**: Public (ticker not available from provided sources; IPO closed as per company announcement)
- **Headquarters**: South San Francisco, California, United States (with additional offices in Princeton, New Jersey and Chicago, Illinois)
- **Founded**: Year not specified in available sources
- **Founders**: Tassos Gianakakos (Co-Founder, CEO & Chair), Dr. Jay Edelberg (Co-Founder & Chief Medical Officer), Dr. Bob McDowell (Co-Founder & Scientific Adviser), Brianne Puglisi (Co-Founder)

## Core Business
- **Primary industry**: Biopharmaceuticals – cardiovascular drug discovery and development
- **Target customers**: B2B / B2G – healthcare providers, hospitals, payers, and patients; the company develops prescription medicines for serious cardiovascular conditions
- **Mission or purpose statement**: “To make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.” ([kardigan.bio](https://www.kardigan.bio/))

## Products & Services
- **Tonlamarsen**: A Phase 2/3 candidate for acute severe hypertension (ASH) and uncontrolled hypertension. Positive Phase 2 data presented as a late-breaker at ACC.26 and simultaneously published in JACC. ([kardigan.bio](https://www.kardigan.bio/))
- **Danicamtiv**: A Phase 3 candidate for genetic dilated cardiomyopathy (DCM), targeting the underlying inherited cardiac muscle disease. ([kardigan.bio](https://www.kardigan.bio/))
- **Calcific Aortic Valve Stenosis (CAVS) Program**: A late-stage clinical program addressing calcium deposition that stiffens the aortic valve. ([kardigan.bio](https://www.kardigan.bio/))
- **Prolaio Subsidiary**: An AI and real‑world data platform integrated into Kardigan to generate insights, inform clinical trial design, and reduce time/cost of drug development. ([kardigan.bio](https://www.kardigan.bio/about-us/))
- **Cardiac Intelligence Platform**: A discovery and translational research engine that uses real‑world patient data, AI, and deep cardiovascular expertise to identify disease drivers and design targeted therapies. ([kardigan.bio](https://www.kardigan.bio/))

## Market Standing
- **Valuation/Market Cap**: Not disclosed in provided sources
- **Key Metric**: Public company (IPO closed); annual revenue not disclosed
- **Notable Investors/Partners**: Not explicitly listed in provided sources; company built on the team’s track record from MyoKardia (acquired by Bristol Myers Squibb for $13.1B in 2020)
- **Growth Signals**:
  - Positive Phase 2 pivotal data for Tonlamarsen in hypertension, presented at ACC.26 and published in JACC
  - Three late‑stage clinical programs (CAVS, ASH, DCM) running in parallel
  - Active job postings across 210+ roles in clinical operations, data science, manufacturing, and corporate strategy, indicating scaling ([job-boards.greenhouse.io/kardigan](http://job-boards.greenhouse.io/kardigan))
  - Integration of Prolaio’s AI platform to accelerate R&D

## Competitive Advantages
- **Leadership expertise**: CEO Tassos Gianakakos previously scaled MyoKardia from startup to a $13.1B acquisition; the team includes veterans from MyoKardia, Sanofi, BMS, and Merck.
- **Parallel pipeline strategy**: Multiple late‑stage programs targeting distinct cardiovascular diseases (valve, hypertension, cardiomyopathy) de‑risks development and creates data synergies.
- **Cardiac Intelligence platform**: Proprietary combination of real‑world data, AI, and deep biological insight to move beyond symptom management toward modifying underlying disease.
- **Focus on functional cures**: Each program aims to alter the course of disease rather than merely treat symptoms, creating potential for breakthrough efficacy.

## Strategic Focus
- **Advance late‑stage clinical trials**: Continue Phase 2/3 studies for Tonlamarsen, Danicamtiv, and CAVS while preparing for potential regulatory submissions.
- **Expand platform capabilities**: Leverage Prolaio’s AI and real‑world evidence to design smarter, faster trials and discover new drug targets.
- **Build commercial infrastructure**: Growing corporate strategy, medical affairs, and manufacturing teams in South San Francisco, Princeton, and Chicago signals preparation for launch.

## Why Work Here
- **Culture**: “Everything we do starts with patients – and it’s powered by people.” Emphasis on collaboration, purpose‑driven work, and achieving the impossible together. Mission‑oriented environment focused on curing cardiovascular disease. ([kardigan.bio](https://www.kardigan.bio/job-openings/))
- **Work model**: Roles are listed for South San Francisco, Princeton, NJ, and Chicago, IL; likely on‑site/hybrid given the lab and clinical development nature. Not purely remote.
- **Benefits**:
  - Competitive salaries and annual bonus program
  - Comprehensive medical, dental, and vision coverage
  - 401(k) plan, life and disability insurance
  - Flexible spending and health savings accounts
  - Commuter benefits, cellphone allowance
  - Paid holidays and time off
  - Employee assistance program ([kardigan.bio](https://www.kardigan.bio/job-openings/))
- **Engineering & data science culture**: Active recruitment for data analytics, AI, and clinical data science roles; Executive Director of Data, AI & Collaboration Services is an open position, reflecting a strong tech‑driven R&D approach.

## Sources
1. [kardigan.bio](https://www.kardigan.bio/) – Company homepage and pipeline descriptions
2. [kardigan.bio/about-us](https://www.kardigan.bio/about-us/) – About Us, mission, and Prolaio integration
3. [kardigan.bio/job-openings](https://www.kardigan.bio/job-openings/) – Careers page with benefits and open roles
4. [kardigan.bio/leadership](https://www.kardigan.bio/leadership/) – Leadership team and co‑founder backgrounds
5. [job-boards.greenhouse.io/kardigan](http://job-boards.greenhouse.io/kardigan) – Detailed job listings (32+ postings)

## Other roles at Kardigan

- [Contracts Manager (Prolaio)](https://feeny.ai/job/contracts-manager-prolaio-kardigan-chicago-42r8rkrddx72) — Chicago, IL
- [Medical Director, Clinical Development](https://feeny.ai/job/medical-director-clinical-development-kardigan-princeton-h0r5qrx667b5) — Princeton, NJ
- [Executive Director, Global Program Manager](https://feeny.ai/job/executive-director-global-program-manager-kardigan-princeton-22n8a9rqn2kb) — Princeton, NJ
- [Senior Director, Biostatistics](https://feeny.ai/job/senior-director-biostatistics-kardigan-princeton-vb12pjj1sw78) — Princeton, NJ
- [Senior Director, Clinical Operations Program Lead](https://feeny.ai/job/senior-director-clinical-operations-program-lead-kardigan-princeton-wswqw80bw3hb) — Princeton, NJ
- [Senior Contracts Manager, Clinical Agreements](https://feeny.ai/job/senior-contracts-manager-clinical-agreements-kardigan-princeton-xthmawfmq41y) — Princeton, NJ
- [Senior Director, Head of Statistical Programming](https://feeny.ai/job/senior-director-head-of-statistical-programming-kardigan-princeton-7ct1vkgyav05) — Princeton, NJ
- [Manager, Forecasting](https://feeny.ai/job/manager-forecasting-kardigan-evanston-qvn5b2dgyy11) — Evanston, IL
- [Manager, Accounting](https://feeny.ai/job/manager-accounting-kardigan-princeton-7tcvpdfvzv82) — Princeton, NJ
- [Executive Director, Regulatory Strategy](https://feeny.ai/job/executive-director-regulatory-strategy-kardigan-princeton-b56gzz2zdy4z) — Princeton, NJ