Director, Clinical Quality Lead at Kardigan

<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{}">&nbsp;</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>&nbsp;</div> <div>Led by Tassos Gianakakos, 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>&nbsp;</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>&nbsp;</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>&nbsp;</div> <div>These values are the foundation of our work, empowering us to make a real difference, every day.</div> <div>&nbsp;</div> <div>&nbsp;</div></div><p>&nbsp;<strong>Position Title: Director, Clinical Quality Lead</strong></p> <p><strong>Department: Quality &amp; Compliance</strong></p> <p><strong>Reports To: Head of CQA</strong></p> <p><strong>Onsite 4 days - M - Th</strong></p> <p><strong>Job Overview</strong></p> <p>The Clinical Quality Lead will play a crucial role in driving a culture of quality and ensuring that compliance is embedded throughout the R&amp;D process.&nbsp; This role will be responsible for managing GxP Quality Assurance (QA) functions and providing consultation in the interpretation of GxP regulations (GCP, GLP, GVP), guidelines, policies, and procedures.&nbsp; This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate.&nbsp;</p> <p>&nbsp;</p> <p><strong>Essential Duties and Responsibilities</strong></p> <p>Essential duties may include the following tasks depending on level of experience</p> <ul> <li>Partners with Clinical Development/Operations and actively participates in clinical study teams to ensure GCP compliance. Reviews study-related documents and plans.</li> <li>Support and maintain the internal audit program, audit schedule, and approved vendor list.</li> <li>Performs internal and external audits as assigned to ensure compliance with GXP regulations and guidelines.</li> <li>Communicates audit results to internal stakeholders and writes audit report.</li> <li>Supports Quality Management System (QMS) including quality oversight and operational support for processes as e.g. CAPAs, audits, inspections, deviation management, risk management, change control and quality complaint handling.</li> <li>Monitor, track, and trend GxP non-conformances, deviations, CAPAs</li> <li>Leads or supports audit and inspection activities, including CAPA formulation, vendor assessments, and regulatory inspections.</li> <li>Responsible for maintaining current regulatory inspection knowledge as it relates inspections by regulatory agencies worldwide</li> <li>Interprets global legislation, regulations and guidance for development or updates to policies and standards, identify gaps and redundancies</li> <li>Leads or supports backroom activities during regulatory authority inspections and assists with GxP inspection readiness activities.</li> <li>Build and maintain cross-functional relationships to promote GxP compliance awareness throughout the R&amp;D organization (GCP, GVP, GLP).</li> <li>Support in training initiatives on processes, new regulations and systems to enable quality compliance.</li> <li>Contribute to defining and monitoring compliance and quality metrics to ensure oversight of processes and projects and management review.</li> </ul> <p>&nbsp;</p> <p><strong>Qualifications and Preferred Skills</strong></p> <ul> <li>Bachelor’s degree in a scientific discipline:</li> <ul> <li>15+ years’ experience in the pharmaceutical or biotechnology industry with in-depth pharmaceutical QMS knowledge and</li> </ul> <li>7+ years in a QMS environment with proven experience in discovery, as well as non-clinical and clinical development.</li> <ul> <li>Direct experience with internal/external clinical systems and process audits</li> <li>Experience in QA audits of Clinical Investigator sites and clinical vendors</li> <li>Experience in the development of SOPs</li> <li>Knowledge and experience in Good Clinical Practices (GCP), Good Laboratory Practice (GLP, and/or Good Pharmacovigilance Practice (GVP) regulations</li> </ul> <li>Strong interpersonal, negotiation, and leadership skills.</li> <li>Excellent written and verbal communication skills, with experience working in a culturally diverse, global team.</li> <li>Ability to work independently and effectively prioritize tasks.</li> <li>Expertise in Root Cause Analysis, CAPA development, and Risk Management methodology.</li> <li>Insightful, decisive, proactive, and solutions-oriented</li> <li>Proven excellence in professional skills including communication, organization, prioritization, discretion, and accuracy</li> <li>Exceptional customer service skills, including cultivating and maintaining close working relationships with both internal and external stakeholders</li> <li>Proficiency in MS Office including Word, Excel, PowerPoint, Outlook, SharePoint, OneNote, and virtual meeting</li> <li>Available to travel as needed</li> <li>Available to be on site 4 days/week</li> </ul> <p>Exact Compensation may vary based on skills, experience and location.</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>$194,000</span><span class="divider">&mdash;</span><span>$253,000 USD</span></div></div></div>