Senior Director, Development Operations & Biometrics, Strategy & Operational Excellence.

The posting, as Kardigan wrote it

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.

Department: Development Operations & Biometrics (DO&BM)

Reports To: Head of Development Operations & Biometrics

Location: Princeton, NJ, United States

Travel: Approximately 10–20%

Job Overview

Kardigan is seeking a Senior Director, DO&BM Strategy & Operational Excellence to serve as a trusted advisor to the Head of DO&BM and the strategic integrator for the function, aligning priorities, governance, operating practices, and cross-functional execution to enable high-quality clinical development across the product lifecycle.

This is a dual-mandate role. On one side, the Senior Director sets and drives DO&BM’s strategic agenda—organizational design, annual planning, governance, performance management, and leadership-team effectiveness—ensuring DO&BM operates as a coordinated, high-performing organization aligned to corporate objectives. On the other, the Senior Director leads the advancement of Risk-Based Quality Management (RBQM), Quality by Design (QbD), process simplification, and data- and technology-enabled ways of working across the clinical development organization.

Reporting directly to the Head of Development Operations & Biometrics, the Senior Director will serve as a trusted strategic partner to senior leaders within DO&BM and partner across Clinical Dev
[…]
ence, Ph.D., or MBA preferred. PMP certification preferred.

• 12+ years of experience in the pharmaceutical or biotech industry, including 5+ years in a leadership, strategy, or transformation capacity, with significant exposure to Clinical Operations and/or Biometrics is preferred.
• Demonstrated experience designing and implementing RBQM and Quality by Design approaches across a clinical development portfolio.
• Proven track record in enterprise strategic planning, operational leadership, and cross-functional collaboration at scale.
• Proven ability to influence senior leaders, build consensus, and drive organizational alignment without direct reporting authority.
• Experience with process excellence methodologies (Lean, Six Sigma) is highly desirable.
• Strong understanding of GCP, compliance frameworks, inspection readiness, and clinical operations.
• Experience applying data, analytics, and emerging technologies—including AI—to clinical development oversight and decision-making.
• Experience building and developing teams in a growing organization.
• Exceptional communication, leadership, and analytical skills.

Success Measures

Success in this role will be demonstrated through

• A DO&BM leadership team that operates as a coordinated, high-performing organization with clear governance, priorities, and accountability.
• Reduced complexity and cycle times across clinical development processes.
• Increased adoption and consistent application of RBQM and Quality by Design principles.
• Improved clinical trial quality and proactive risk identification.
• Increased use of data and analytics in operational and quality decision-making.
• Improved inspection readiness and compliance.
• Successful adoption and sustainability of new processes, technologies, and operating models.
• Increased stakeholder engagement and measurable growth in organizational capability.
• Demonstrable business impact from transformation and continuous improvement initiatives.