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.

About the Team
Kardigan’s Regulatory Affairs team is a collaborative and strategic partner in advancing our portfolio of investigational cardiovascular therapies. Working closely with colleagues across Clinical Development, Medical Affairs, Safety, CMC, Quality and other functions, the team translates evolving science and development plans into clear regulatory strategies that support high-quality decisions and productive engagement with global health authorities.

We are building a team that combines scientific rigor, sound judgment, and a practical, solutions-oriented mindset. Team members have the opportunity to shape regulatory approaches, establish scalable ways of working, and influence programs at important stages of development. Our work helps Kardigan move with urgency while maintaining the highest standards of quality, ethics, and compliance, ultimately supporting our mission to bring potentially transformative treatments to people living with cardiovascular disease.

Job Overview
Kardigan is seeking an Executive Director, Regulatory Strategy to lead global regulatory strategy across our portfolio of investigational cardiovascular therapies. Reporting to the SVP, Regulatory Affairs, this leader will serve as the regulatory lead on program teams, own the development and execution of regulatory strategy in line with the integrated development plan for late-stage clinical programs, and act as the primary interface with the U.S. Food and Drug Administration while directing ex-US regulatory activities with support from consultants, vendors, and partners.

This is a high-ownership role in a fast-paced, entrepreneurial environment. The Executive Director will help define regulatory pathways for investigational therapies, including in indications without established regulatory precedent, and will help build Kardigan’s regulatory capabilities, processes, and team as the portfolio matures. Early priorities include refining program regulatory strategies and health authority engagement plans, establishing regulatory risk registers and regulatory intelligence monitoring, contributing to core regulatory processes and infrastructure, and managing the consultants and vendors supporting the portfolio. Significant regulatory strategy decisions and major agency positions will be developed in partnership with, and subject to alignment with, the SVP, Regulatory Affairs and the Executive Leadership Team.

Main Responsibilities
• Lead the development and execution of the regulatory strategy in line with the integrated development plan for late-stage clinical programs, ensuring alignment with corporate objectives and applicable global regulatory requirements.
• Interface with internal and external stakeholders to develop and implement cross-portfolio global regulatory strategies in line with business objectives.
• Serve as the primary point of contact with the FDA — including meeting requests, briefing materials, day-to-day correspondence, and responses to information requests — and direct ex-US regulatory activities with support from consultants, vendors, and partners.
• Lead preparation and execution of formal health authority meetings (e.g., Type B/C, End-of-Phase 2, and pre-NDA/pre-MAA meetings), including briefing documents and cross-functional rehearsals.
• Independently contribute to and/or oversee the planning, compilation, review, approval, and submission of regulatory documents, including initial INDs/CTAs/NDAs/MAAs and amendments or supplements, meeting packages, expedited-program and designation requests where supported by the data (e.g., Breakthrough Therapy, Fast Track), annual reports, and Investigator’s Brochures.
• Ensure regulatory documents and submissions are accurate, complete, verifiable, and compliant with applicable FDA, ICH, and global requirements, and that regulatory databases, submission logs, and correspondence logs are maintained.
• Provide quality regulatory input and strategic perspective across all stages of drug development — including clinical development plans, protocol design, endpoint strategy, and evidence-generation planning — to support informed decision-making and optimize the company’s regulatory approaches for product development and lifecycle management.
• Lead development and maintenance of the labeling strategy, partnering with Clinical Development, Medical Affairs, and Commercial to align on the evidence required to support them and to prepare the organization for labeling discussions with health authorities.
• Partner closely with Regulatory CMC to ensure alignment of overall development strategies and integrated, submission-ready regulatory content.
• Identify and assess regulatory risks associated with development programs and define approaches to mitigate them; communicate risk assessments, scenario planning, and mitigation strategies to program teams, the SVP, Regulatory Affairs, and the Executive Leadership Team, surfacing risks early with clear, well-reasoned recommendations.
• Directly oversee regulatory responsibilities outsourced to CROs, consultants, and vendors, ensuring quality, strategic alignment, and compliance with applicable regulations and guidelines; provide regulatory due diligence and strategic input for business development opportunities as needed.
• Review, write, and present guidelines and SOPs as needed to support high-quality submissions and ensure cross-functional adherence to regulatory requirements.
• Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration; monitor, interpret, analyze, and disseminate regulatory intelligence that may affect ongoing development.
• Hire, develop, and mentor regulatory professionals, fostering accountability and a culture of collaboration.

About You
Basic Qualifications
• Bachelor of Science in a scientific discipline.
• Minimum of 10 years’ experience in pharmaceutical regulatory activities, with experience as a leader accountable for global regulatory product strategy.
• Extensive experience developing and implementing complex regulatory strategies, leading and managing regulatory teams, regulatory submissions (INDs, NDAs, and MAAs), product lifecycle management, and Health Authority interactions.
• Matrix leadership: proven ability to lead cross-functional teams across clinical, regulatory, biometrics, data management, clinical operations, and commercial driving alignment on a unified development plan while safeguarding scientific and analytical integrity.
• Must have excellent verbal and written communication skills, demonstrating the ability to communicate complex ideas in an easily understandable way.
• Hands-on professional capable of working collaboratively and independently.
• Excellent planning, organization and time management skills, including the ability to support and prioritize multiple projects.
• Demonstrated management experience, including leadership and development of employees.
• Current and strong working knowledge of regulatory requirements including GxP, eCTD submission standards, and ICH guidelines.

Preferred Qualifications
• Advanced degree in a scientific discipline.

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

Pay range

$266,000—$346,000 USD

Pay range 266000 - 346000 USD

About the company

Kardigan develops medicines to prevent and treat cardiovascular disease. It focuses on discovering and developing multiple cardiovascular therapies at a rapid pace, using deep expertise in heart-health drug development to move candidates from research toward commercialization. Their product approach centers on creating medicines that address heart disease more effectively and earlier in the disease process. Kardigan differentiates itself through a leadership team of seasoned biopharma veterans and a commitment to modernizing how cardiovascular drugs are discovered and developed, aiming to bring therapies to patients faster and more efficiently. The company’s goal is to reduce the global burden of cardiovascular disease by providing safe, effective medicines that prevent progression or cure conditions related to heart health.

Company Size

201-500

Company Stage

IPO

Headquarters

West Windsor Township, New Jersey

Founded

2023

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Simplify's Take

What believers are saying

June 2026 IPO raised $460 million gross, lifting cash to $660.7 million.
August 2026: KINSHIP-DCM Phase 3 started, while KARDINAL-ASH enrolled its first patient.
ESC 2026 presentations and 1H 2027 topline data keep multiple catalysts ahead.

What critics are saying

Kardigan reported $116.2 million Q2 2026 losses, burning IPO cash quickly.
All three programs need successful 1H 2027 readouts; one failure could erase valuation.
No product revenue exists; another financing round before 2028 would dilute shareholders.

What makes Kardigan unique

Tassos Gianakakos and Jay Edelberg built MyoKardia’s mavacamten playbook, then Kardigan.
Kardigan pairs Prolaio AI with late-stage cardio trials for narrower, faster registrational studies.
Danicamtiv, ataciguat, and tonlamarsen target separate unmet cardiovascular niches without approved therapies.

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Benefits

Hybrid Work Options

Growth & Insights and Company News

6 month growth

21%

1 year growth

19%

2 year growth

34%

U.S. Securities and Exchange Commission

Oct 27th, 2026

10-Q

Condensed Consolidated Statements of Operations and Comprehensive Loss

U.S. Securities and Exchange Commission

Oct 20th, 2026

Final Prospectus 424(b)(4)

Filed Pursuant to Rule 424(b)(4)Registration No. 333-296236 and 333-296870

Citybiz

Sep 30th, 2026

Kardigan appoints Google finance executive Kristin Reinke to Board of Directors.

Kardigan appoints Google finance executive Kristin Reinke to Board of Directors. September 30, 2026 Kristin Reinke Kardigan Inc. has appointed longtime Google finance executive Kristin Reinke to its Board of Directors, where she will serve as Chair of the Audit Committee as the precision cardiovascular company advances its late-stage pipeline and continues its evolution as a public company. Reinke's appointment is effective Sept. 29. Doug Giordano, a founding member of Kardigan's board, is stepping down on the same date. Reinke is currently Vice President of Finance at Google, where she leads efforts to apply artificial intelligence to modernize and scale the company's finance organization. She has been a member of Google's finance leadership team since 2005, with responsibilities over the years spanning global financial planning and analysis, capital allocation and controllership. Her appointment adds experience in financial governance and technology-enabled operations to Kardigan's board as the Nasdaq-listed biotechnology company works to advance its cardiovascular drug pipeline toward potential commercialization. "Kristin's proven track record leading AI-driven transformation at global scale will be a great asset to help us achieve our mission of changing the future of cardiovascular care," said Tassos Gianakakos, Co-Founder, Chief Executive Officer and Chair of the Board of Kardigan. Kardigan also expects Reinke's technology background to support its integration of Prolaio's data and analytics platform into the company's product development operations. The company is developing an integrated approach that combines cardiovascular biology, real-world patient data and advanced analytics to inform drug discovery and clinical development. Its pipeline focuses on cardiovascular diseases for which no approved treatments currently exist. "Her experience turning technology into an operational advantage will be invaluable as we integrate Prolaio's data and analytics platform into our product development, and her financial governance expertise will help guide our late-stage pipeline toward potential commercialization," Gianakakos said. Reinke joined Google when the company was considerably earlier in its development and has remained with its finance organization as the business expanded into a multibillion-dollar global enterprise. Before Google, she held leadership positions at Oracle and began her career at Arthur Andersen. Reinke also serves as an independent director of Everly Health, where she chairs the Audit Committee. She is a Certified Public Accountant and holds a bachelor's degree in accounting from Michigan State University. Her appointment comes alongside the departure of Giordano, whom Gianakakos credited for his role in the company's development as a founding board member. "We also would like to thank Doug, a founding member of our Board, for his profound impact over the last few years," Gianakakos said. Kardigan, which trades on Nasdaq under the ticker KARD, is a clinical-stage precision cardiovascular company developing therapies designed to address the underlying causes of cardiovascular diseases. The company is using patient data and analytics alongside its cardiovascular research capabilities to support more targeted drug development. With Reinke taking leadership of the Audit Committee, Kardigan is adding public-company financial oversight and large-scale technology experience to its board as it prepares its development programs for their next stages and builds the infrastructure required for potential commercialization.

Yahoo Finance

Sep 30th, 2026

Kardigan announces appointment of Kristin Reinke to its Board of Directors.

Kardigan announces appointment of Kristin Reinke to its Board of Directors. SOUTH SAN FRANCISCO, Calif. & PRINCETON, N.J., September 30, 2026-(BUSINESS WIRE)-Kardigan(TM), Inc. (Nasdaq: KARD) ("Kardigan"), a precision cardiovascular company, announced today the appointment of Kristin Reinke to its Board of Directors, where she will serve as chair of the Audit Committee. As part of the Board's public company evolution, Doug Giordano will be stepping down from the Board. Both Ms. Reinke's appointment and Mr. Giordano's departure are effective as of September 29, 2026. "Kristin's proven track record leading AI-driven transformation at global scale will be a great asset to help us achieve our mission of changing the future of cardiovascular care. Her experience turning technology into an operational advantage will be invaluable as we integrate Prolaio's data and analytics platform into our product development, and her financial governance expertise will help guide our late-stage pipeline toward potential commercialization. We're thrilled to welcome Kristin to the Kardigan Board and are fortunate to have her chair our Audit Committee," said Tassos Gianakakos, co-founder, chief executive officer, and chair of the board of Kardigan. "We also would like to thank Doug, a founding member of our Board, for his profound impact over the last few years." Ms. Reinke is currently vice president of finance at Google, where she leads the application of AI to modernize and scale the company's finance organization. A member of Google's finance leadership team since 2005, she has held roles spanning global FP&A, capital allocation, and controllership, helping the company grow from a startup into a multibillion-dollar global enterprise. She previously held leadership roles at Oracle and began her career at Arthur Andersen. Ms. Reinke serves on the board of Everly Health as an independent director and the audit committee chair. She is a CPA and holds a bachelor's degree in accounting from Michigan State University. About Kardigan Kardigan is a clinical-stage precision cardiovascular company developing medicines that target the root cause of diseases where no approved treatments exist. Led by a proven and experienced management team, Kardigan is reimagining cardiovascular drug discovery and development through an integrated approach that unites deep cardiovascular biology, real-world patient data, and advanced analytics to enable more precise, efficient, and informed development of novel therapies. Learn more about Kardigan and its mission at Kardigan.bio. Media: Michael Bachner Executive Director, Corporate Communications +1 (609) 664-7308 [email protected] Investors: Clayton Robertson Vice President, Investor Relations [email protected]

MarketScreener

Jun 18th, 2026

Kardigan makes strong Nasdaq debut following upsized IPO.

Kardigan makes strong Nasdaq debut following upsized IPO. Kardigan delivered a notable market debut on the Nasdaq, raising $400m in an upsized initial public offering. Shares of the cardiovascular treatment specialist opened at $16.25, above the $16 IPO price, before climbing more than 22% during the session. This performance underscores a resurgence in investor appetite for biotechnology firms boasting advanced clinical programs and robust growth prospects. Published on 06/18/2026 at 03:52 pm EDT Based in Princeton, New Jersey, Kardigan is developing several precision therapies for cardiovascular diseases. Its pipeline notably includes drug candidates danicamtiv, ataciguat, and tonlamarsen. Management has indicated that pivotal data regarding these three programs are expected during the first half of next year. The company was founded by Tassos Gianakakos and Jay Edelberg, two former executives who played key roles in the development of the heart medication mavacamten at MyoKardia, which was acquired by Bristol Myers Squibb for $13bn in 2020. This transaction takes place within a more favorable environment for biotech IPOs following several years defined by tighter access to capital. However, analysts point out that Kardigan may require additional financing in the medium term. The company stated in its regulatory filings that its current resources would not be sufficient to fund operations for at least twelve months without further capital injections, even though the funds raised are intended to accelerate the development of its clinical programs. (C) MarketScreener.com - 2026

Kardigan

Executive Director - Regulatory Strategy

About the job