---
title: 'Senior Director, CMC Regulatory at Kardigan'
canonical: 'https://feeny.ai/job/senior-director-cmc-regulatory-kardigan-south-san-francisco-california-xjzf831d0r9n'
type: 'job'
last_seen: '2026-09-12'
---

# Senior Director, CMC Regulatory at Kardigan

- **Company:** Kardigan
- **Location:** South San Francisco California, United States
- **Compensation:** $248k–$310k
- **Posted:** 2026-08-26
- **Last confirmed live:** 2026-09-12
- **Apply:** https://job-boards.greenhouse.io/kardigan/jobs/5405745008

## 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.

Position Title: Senior Director, CMC Regulatory

Department: Regulatory Affairs

Reports To: Head of CMC Regulatory

Location: South San Francisco, CA (onsite 4 days per week)

Job Overview

Kardigan is seeking a Senior Director, CMC Regulatory to support Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases closer to the cures they deserve. The Senior Director will be responsible for leading CMC Regulatory activities to help advance Kardigan’s late-stage clinical assets through clinical development and towards marketing approval. We are looking for a highly motivated individual who will help define CMC Regulatory strategies and successfully execute them in submissions and health authority interactions, in close collaboration with cross-functional partners. This position will report to the Head of CMC Regulatory.

Essential Duties and Responsibilities

- Lead the development and execution of CMC regulatory strategies, working in close collaboration with cross-functional teams to ensure regulatory strategies are aligned with program objectives and timelines
- Proactively manage regulatory CMC aspects of programs to ensure on-time delivery of global, high-quality submissions across all development-stage programs
- Manage regulatory interactions with global health authorities, including meeting preparation and participation, responses to questions, and negotiations.
- Provide regulatory expertise on CMC strategies to cross-functional teams, anticipating regulatory concerns, and proposing innovative solutions.
- Ensure compliance with relevant global CMC requirements (FDA, EMA, and ICH guidelines), and proactively monitor regulatory trends, guidance documents and changes to existing regulations.
- Evaluates proposed manufacturing and quality changes for impact to ongoing and existing submissions and provides strategic regulatory guidance for optimal implementation of changes.
- Help develop and implement department practices, policies, processes, and SOPs
- Manage internal or external staff as needed

## Qualifications and Preferred Skills

- Bachelor’s degree in scientific discipline required, advanced degree in Chemistry preferred
- Minimum of 10 years industry experience with majority of experience in CMC Regulatory Affairs or related roles
- Experience with global early and late phase submissions (IND/IMPD and NDA/MAA, amendments, and annual reports) and health authority interactions
- Prior small molecule experience preferred
- Excellent knowledge of FDA, EMA and ICH regulatory guidelines and regulations
- Collaborate and communicate well with all levels of employees, including peers, executives and cross-functionally
- Strong interpersonal, communication (oral and written), and organizational skills
- Ability to handle and prioritize multiple assignments, and work in a fast-paced environment.

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

Pay range $248,000—$310,000 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)

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