Associate Director, Clinical Trial Lead (Princeton, NJ/ South San Francisco)

<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{}"> </span></p> <div data-olk-copy-source="MessageBody">Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.<br><br></div> <div>It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.</div> <div> </div> <div>Led by Tassos Giannakakos, Jay Edelberg, <span data-olk-copy-source="MessageBody">M.D., Ph.D.,</span> 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.</div> <div> </div> <div>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.</div> <div> </div> <div>At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. <strong>Driven by patients and their families</strong>, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in <strong>being authentic</strong>—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 <strong>eagerness to learn</strong>, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to <strong>winning as a team</strong> with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to <strong>enable the impossible</strong> because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.</div> <div> </div> <div>These values are the foundation of our work, empowering us to make a real difference, every day.</div> <div> </div> <div> </div></div><p>Kardigan is seeking an Associate Director, Clinical Trial Lead to manage one of its cardiovascular clinical studies. As a Clinical Trial Lead (CTL), you will be part of the Clinical Operations team reporting to the asset’s Clinical Operations Program Leader (COPL).  As a Global 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.</p> <p> </p> <p>This position is 4-day onsite position in Princeton, NJ. (May consider onsite in South San Francisco)</p> <p> </p> <p><strong>Key Responsibilities:</strong></p> <p> </p> <p><strong>Trial Leadership & Oversight</strong></p> <ul> <li>Lead the planning, execution, and delivery of assigned clinical trials (global or regional scope).</li> <li>Drive study timelines, milestones, and deliverables from synopsis through Clinical Study Report.</li> <li>Serve as the primary operational point of contact for the cross-functional study team.</li> <li>Align team execution with the study’s regulatory submission strategy and overall development plan.</li> </ul> <p><strong>Study Start-Up & Execution</strong></p> <ul> <li>Oversee site feasibility, selection, initiation, and activation; delegate to Clinical Trial Managers (CTMs) as appropriate.</li> <li>Partner with CTMs to ensure vendor and site readiness across start-up, enrollment, monitoring, and closeout.</li> <li>In partnership with the COPL, develop and execute participant recruitment strategies; review and approve operational plans, study manuals, and charters.</li> <li>Lead operational strategy related to drug supply, remote monitoring, and decentralized trial processes.</li> </ul> <ul> <li>Collaborate closely with the Clinical Development Lead on protocol development, amendments, and master ICFs.</li> <li>Liaise with cross-functional team representatives to ensure cohesive trial execution.</li> </ul> <p><strong>Vendor Management</strong></p> <ul> <li>Provide input into CRO and vendor selection, ensuring alignment with trial needs and operational strategy.</li> <li>Direct and manage CRO and vendor partnerships, holding them accountable for timelines, quality, and budget commitments.</li> <li>Drive management of CROs, vendors, and external partners through oversight, escalation, and proactive issue resolution.</li> </ul> <p><strong>Budget & Resource Management</strong></p> <ul> <li>Contribute to initial trial budget development and ongoing financial oversight.</li> <li>Review and approve CRO/vendor work orders and change orders for accuracy and completeness.</li> </ul> <p><strong>Quality, Compliance & Risk Management</strong></p> <ul> <li>Ensure compliance with ICH-GCP, local regulations, and company SOPs.</li> <li>Oversee and coordinate the review of protocol deviations; manage amendments with cross-functional alignment.</li> <li>Partner with Data Management to develop and approve data cleaning plans.</li> <li>Maintain decision, action, and risk logs; escalate issues proactively and implement CAPAs when required.</li> <li>Contribute to inspection readiness and support audits and regulatory inspections.</li> </ul> <p><strong>Reporting & Documentation</strong></p> <ul> <li>Coordinate responses to health authorities, ethics committees, and IRBs as needed.</li> <li>Review and contribute to clinical study reports and regulatory filings.</li> </ul> <p><strong> </strong></p> <p><strong>People Management</strong></p> <ul> <li>May directly manage Clinical Trial Associates (CTAs), Clinical Trial Managers (CTMs), or other assigned staff (e.g. contingent workers).</li> <li>Provide coaching, feedback, and performance management to direct reports.</li> <li>Support career development and training to build functional and leadership capabilities within the team.</li> <li>Lead by example, fostering a collaborative and high-performance culture.</li> </ul> <p> </p> <p><strong>Here’s What You’ll Bring to the Table:</strong></p> <ul> <li>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.</li> <li>Experience within the field of cardiovascular studies and/or rare disease is desirable.</li> <li>Experience in early and late phase drug development; late-stage (Phase 2/3) development experience is <strong>required.</strong></li> <li>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.</li> <li>Excellent communication skills, both verbal and written</li> <li>Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence.</li> </ul> <ul> <li>Confidence to challenge status-quo thinking and behavior</li> <li>Can work with agility and an innovative mindset.</li> </ul> <ul> <li>Experience in ICH/GCP inspections, audits and inspection preparedness</li> <li>Experience in mentoring Clinical Operations staff</li> </ul> <p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>Exact Compensation may vary based on skills, experience and location.</p></div><div class="title">Pay range</div><div class="pay-range"><span>$175,000</span><span class="divider">—</span><span>$228,000 USD</span></div></div></div>