Job Details

Overview

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 Kardigans mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Kardigans co-founders led MyoKardia to discover and develop mavacamten, resulting in an acquisition by Bristol Myers Squibb in 2020. Kardigan has 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 authenticleading 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.

Kardigan is seeking an Associate Director, Clinical Trial Lead (CTL) to manage its cardiovascular clinical studies. As a CTL, you will be part of the Clinical Operations team reporting to the assets Clinical Operations Program Leader (COPL). The CTL is accountable for the operational delivery of the assigned clinical trial, serving as the primary operational contact and leader for the cross-functional study execution team. The CTL may lead trials at a global level (overseeing multi-regional execution) or at a regional level (driving operational delivery in assigned countries/territories), depending on business needs. As a global or regional CTL, you will ensure that key project deliverables are met according to the budget and timelines and quality standards (as defined by regulations, SOPs, and ICH-GCP) with the overall goal of developing new and innovative treatments for cardiovascular diseases with unmet need.

Kardigan is a 4-day onsite company (M - Th)

Key Responsibilities

• Lead the planning, execution, and delivery of assigned clinical trials (global or regional), ensuring alignment with regulatory submission strategy and development plans.
• Serve as the primary operational contact for cross-functional teams, CROs, vendors, and sites; provide input into partner selection and oversee performance against timelines, quality, and budget.
• Oversee site, CRO and vendor readiness across feasibility, start-up, enrollment, monitoring, and closeout, delegating and partnering with Clinical Trial Managers and Associates as appropriate.
• Drive recruitment strategies, operational plans, and execution of innovative trial processes (e.g., drug supply, remote monitoring, decentralized approaches).
• Ensure trial compliance with ICH-GCP, SOPs, and regulations; proactively manage risks, protocol deviations, CAPAs, and inspection readiness.
• Contribute to budget oversight, work order/change order reviews, and ongoing financial management.
• Review and approve key trial documentation, including protocols, amendments, ICFs, operational manuals, regulatory responses, and clinical study report.
• May directly manage Clinical Trial Associates (CTAs), Clinical Trial Managers (CTMs), or other assigned staff (e.g. contingent workers).
• Lead by example, fostering a collaborative and high-performance culture.

Requirements

• Minimum of BA/BS with approximately 10 years of experience in global clinical trial management roles from pharmaceutical companies and/or CROs. Advanced degree preferred.
• Experience within the field of cardiovascular studies and/or rare disease is desirable.
• Experience in early and late phase drug development; some late-stage development experience is preferred.
• 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.
• Excellent communication skills, both verbal and written
• Travel to conferences, meetings, clinical trials sites and Kardigan locations required ~30% time
• Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence.
• Can work with agility and an innovative mindset.
• Experience in ICH/GCP inspections, audits and inspection preparedness