Senior Director, Clinical Operations Program Lead

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.

Position Title: Sr. Director Clinical Operations Program Lead

Department: Development

Reports To: Head of Clinical Operations

Location: Princeton, New Jersey

Job Overview

Kardigan is seeking a Senior Director, Clinical Operations Program Lead for a late-stage cardiovascular asset. This position will be responsible for leading all of the activities associated with the clinical studies for the asset across all phases, including overseeing the internal operations team, CROs and vendors and working cross-functionally on the operational strategy and related initiatives. This position reports to the Head of Development Operations and serves as a member of the Development Operations Leadership team. This position will work collaboratively across the department, the entire Kardigan portfolio and cross-functional core/project teams with the overall goal of developing new and innovative treatments for cardiovascular diseases with unmet need.

Essential Duties and Responsibilities

• Accountable for the delivery of the assigned clinical program’s budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
• Develop and present the operational str

[…]
al and operating model related initiatives

• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Kardigan’s, including Prolaio
• Directly manage assigned Clinical Trial Leads with a focus on performance, coaching and career development; provide mentorship to Site Operations Managers/Associates by providing clinical operations expertise and support identification and prioritization of study and program level work.
• Strive for continuous improvement and more efficient ways of working in clinical development

Qualifications and Preferred Skills

• Minimum of BA/BS with at least 12 years of global clinical trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience. Advanced degree preferred.
• Experience within the field of cardiovascular or rare disease studies is preferred.
• Robust experience in early and late phase drug development; some late-stage development experience is required.
• Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
• Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
• Experience in ICH/GCP inspections, audits and inspection preparedness
• Outstanding communication skills, both verbal and written
• Excellent organizational skills and ability to work independently
• Confidence to challenging status-quo thinking and behavior; can work with agility and an innovative mindset.

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

Pay range
$247,000 — $322,000 USD